U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
Reason
Labeling error. kits contains the correct components for ak-42802-sk but may have a package label indicating that it is product number ak-22802-sk.
Action
The recalling firm issued a recall letter dated 9/27/04 to their accounts informing them of the problem and the need to return the product.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Electrode, Electrosurgical - Product Code JOS
Reason
Improper wire placement from the patient plate to the esu connector plug results in an intermittent displacement connection.
Action
A recall notification letter dated 09/30/2004 was sent to Hospitals and Health Care Distributors instructing consignees to immedately remove all effective product from lot 2007-06 HP.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Electrosurgical Electrode Kit - Product Code NWI
Reason
Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ecg.
Action
Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Culture Media, Enriched - Product Code KZI
Reason
The product does not perform as intended with some quality control organisms (haemophilus influenzae).
Action
The recalling firm notified their customers via telephone on 9/27/04 requesting they examine their inventory and discard the recalled lot.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device.
Action
The recalling firm issued a letter to their customers dated 4/8/04 informing them of the problem. The letter explained that the manual was changed due to unacceptable text. The consignees were instructed to change the user manuals prior to shipping.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Pump, Infusion, Insulin - Product Code LZG
Reason
Suspend mode not functioning properly.
Action
The recalling firm issued a notice entitled 'Important Safety Information Regarding the Animas IR 1200 Pump' dated 9/28/04 to the health care professionals and distributors. The letter informed the reader of the problem and to use an alternate feature. Health care professionals should notify patients of the problem.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
System, X-Ray, Tomography, Computed - Product Code JAK
Reason
Calcium scoring feature on this devices is not closing properly after patient's exams.
Action
The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
System, X-Ray, Tomography, Computed - Product Code JAK
Reason
Calcium scoring feature on this devices is not closing properly after patient's exams.
Action
The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
System, X-Ray, Tomography, Computed - Product Code JAK
Reason
Calcium scoring feature on this devices is not closing properly after patient's exams.
Action
The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer - Product Code NIG
Reason
A software upgrade was released by the firm for its aia-600 ii analyzers, in that washing deficiencies caused by the analyzer were corrected.
Action
The firm initiated the correction on 4/2/03 via telephone calls and PR on 11/24/04 to all its direct customers, however, the firm indicated that software upgrade was accomplished by the firm's Field Service Engineers.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Implant, Cochlear - Product Code MCM
Reason
All unimplanted clarion and hiresolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning.
Action
Expanded recall was initiated with notification to clinicians on 9/27/2004. Expanded effort includes: notice to patients implanted, notice to clinicians, worldwide return of all unimplanted coclear implants.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Stains, Microbiologic - Product Code JTS
Reason
Reagent for microbiological testing may cause inconsistent staining characteristics and subsequent misidentification of bacteria in patient samples.
Action
The recalling firm notified distributors and direct accounts by fax, certified letter, and e-mail on 9/29/04. The notifications advised that staining characteristics may not be appropriate, and that product should be discarded for replacement. Distributors were additionally requested to provide a consignee list for direct notification by BD. Consignees were requested to return response form.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
System, X-Ray, Tomography, Computed - Product Code JAK
Reason
Calcium scoring feature on this devices is not closing properly after patient's exams.
Action
The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
System, X-Ray, Tomography, Computed - Product Code JAK
Reason
Calcium scoring feature on this devices is not closing properly after patient's exams.
Action
The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
System, X-Ray, Tomography, Computed - Product Code JAK
Reason
Calcium scoring feature on this devices is not closing properly after patient's exams.
Action
The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
System, X-Ray, Tomography, Computed - Product Code JAK
Reason
Calcium scoring feature on this devices is not closing properly after patient's exams.
Action
The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
System, X-Ray, Tomography, Computed - Product Code JAK
Reason
Calcium scoring feature on this devices is not closing properly after patient's exams.
Action
The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Genital protector shield used with fuji computed radiography (fcr) system models 5501d and xu/d1.
model: gp344 may detach from the mounting block and fall during use.
Action
Fuji are notifying users through Fuji service representatives who are hand delivering the notfication letter dated 9/30/04 and installing the mandatory hardware upgrade.