Devices

Device Recall Philips

Model / Serial
Devices with a Laird Chiller.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide, worldwide including Canada
Product Description
The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20 722006; Allura Xper FD20/10 and FD20/20 722008; Allura Xper FD10 722010; Allura Xper FD10/10 722011; || Allura Xper FD20 722012; Allura Xper FD20 biplane 722013; Allura Xper FD10 OR Table 722014; Allura Xper FD20 OR Table 722015; Allura Xper FD10/10 OR Table 722019; Allura Xper FD20 Biplane OR Table 722020; Allura Xper FD10 OR Table 722022; Allura Xper FD20 OR Table 722023; Allura Xper FD10/10 OR Table 722024; Allura Xper FD20 Biplane OR Table 722025; || Allura CV20 722031
Manufacturer
Philips Electronics North America Corporation
2 Events
- Recall of Device Recall Philips
- Recall of Device Recall Philips

Manufacturer

Philips Electronics North America Corporation

Manufacturer Address
Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
Manufacturer Parent Company (2017)
Philips
Source
USFDA

229 devices with a similar name

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Device Recall Philips Healthcare Allura XPER FD20

Model / Serial
Site Numbers: 103331, 520481, 537743, 43721190, 43796227, 51126900, and 51333259.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- US, including states of CA, IL, MA, NC, and OC.
Product Description
Allura XPER FD 20 and and Allura CV20; || Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura CV20. || Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
Manufacturer
Philips Medical Systems North America Co. Phillips

Device Recall Philips IntelliVue Clinical Information Portfolio

Model / Serial
versions D.03, E.0, or E.01 of the software
Product Classification
General Hospital and Personal Use Devices
Device Class
Unclassified
Implanted device?
No
Distribution
Worldwide distribution: USA, Canada, Australia, Austria, Belgium, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Kenya, Latvia, Malaysia, Netherlands, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
Product Description
Philips IntelliVue Clinical Information Portfolio software as follows: || 865047 IntelliVue Clinical Information Portfolio Release D.03; 865209 IntelliVue Clinical Information Portfolio Release E.0 and E.01; 865300 IntelliVue Clinical Information Portfolio NICU Link
Manufacturer
Philips Healthcare Inc.

Device Recall PHILIPS MODEL MX 16slice Computed Tomography Scanners

Model / Serial
Serial numbers are: P16C080002, P16E080005, P16E080007, P16E080008, P16E080012, P16E080010, P16E090004, P16E090008, P16E090005, P16E080007, P16E080008, P16E080012, P16E080010, P16E090004, P16E090008, P16E090005, P16E090006, P16E090007, P16E090009, P16E090012, P16E090003, P16E090010, P16E090011, P16E090013, P16EM09003, P16EM09004, P16E090002, P16E090014, P16E090015, P16EM08003, P16E090016, P16E090018, P16E090019, P16E090020, P16E090021, P16E090026, EP16E090001, P16E090028, P16E090027, P16E090017, P16EM09002, P16E090024, P16E090025, EP16E090002, EP16E090003, EP16E090004, EP16E090006, EP16E090007, EP16E090008, EP16E090009, P16C090001, EP16E090010, EP16E090011, EP16E090012, EP16E090014, EP16E090015, EP16E100001, EP16E100002, EP16E100004, EP16E100003, EP16E100005, EP16E100006, EP16E100007, EP16E090013, EP16E100008, EP16E100009, EP16E100010, P16C100001, EP16E100011, EP16E100012, EP16E100013, EP16E100014, EP16E100015, EP16E100016, EP16E100017, EP16E100018, EP16E100019, P16C080001, EP16E100020, EP16E100021, EP16E100022, EP16E100023, EP16E100024, EP16E100027, EP16E100026, EP16E100030, EP16E100031, EP16E100029, P16C100003, EP16E100025, EP16E100028, P16C100002, EP16E100034, EP16E100033, EP16E100032, EP16E100035, EP16E100036, EP16E100037, P16E100002, P16C100004, EP16E100039, EP16E100038, EP16E100042, EP16E100043, EP16E100041, EP16E100044, EP16E100046, EP16E100045, EP16E100048, EP16E100047, EP16E100051, EP16E100049, EP16E100050, EP16E100053, EP16E100052, EP16E100054, EP16E100056, EP16E100055, P16C100005, EP16E100057, EP16E100058, EP16E100059, EP16E100060, EP16E100061, EP16E100062, EP16E100063, P16C100007, EP16E100067, EP16ER100003, EP16ER100004, EP16ER100005, EP16E100070, EP16E100069, EP16E100071, EP16E100072, EP16E100073, EP16E100074, EP16E100078, EP16E100075, EP16E100076, EP16E100077, EP16E100079, EP16E100080, EP16E100082, EP16E100081, EP16E100083, EP16E100084, P16C100008, P16C100009, EP16E100085, EP16E100086, EP16E100087, P16C100010, EP16E100088, EP16E100089, EP16E100090, EP16E100091, EP16E100093, EP16E100094, EP16E100092, P16C100014, P16C100015, EP16E100095, P16C100011, EP16E100096, EP16E100097, EP16E100098, P16C100017, EP16E100099, EP16E100100, EP16E100101, EP16E100102, P16C100013, EP16E100103, EP16E100104, EP16E100105, EP16E100106, EP16E100109, EP16E100107, P16C100012, EP16E100108, EP16E100111, EP16E100110, P16C100018, EP16E100112, EP16ER100008, EP16ER100007, EP16E100113, EP16E110003, EP16E110001, EP16E110002, EP16E110004, and EP16E110005.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- United States (AL, AR, CA, FL, GA, IL, IN, MS, NJ, NV, NY, OH, PA, SC and TX) including Puerto Rico and countries of Albania, Argentina, Australia, Belgium Brazil, Chile, Columbia, Dominican Republic, Ecuador, Germany, Greece, India, Indonesia, Italy, japan, Kenya, Lebanon, Malawi, The Netherlands, Philippines, Poland, Romania, Saudi Arabia, South Africa, Spain, Switzerland, Turkey, Uganda, United Arab Emirates and Venezuela
Product Description
MX 16-slice Computed Tomography Scanners, equipped with Software Version 1.1.1. Model #E989605657371. || The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients.
Manufacturer
Philips Medical Systems (Cleveland) Inc

Device Recall Philips AudioVideo Engineering PAS210 Remote Active Speakers Kit

Model / Serial
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and the country of Canada
Product Description
Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center || The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
Manufacturer
Philips Healthcare Inc.

Device Recall Philips MRx Defibrillator

Model / Serial
Model M3535A: US00100100 to US00576623 Model M3536A: US00100902 to US00576650 Model M3536J: US00209838 to US00332675 Model M3536M: US00500002 to US00553553 Model M3536MC: US00500001 to US00500087 Model M3536M2: US00554176 to US00554178 Model M3536M4: US00500003 to US00574869 Model M3536M5: US00500001 to US00562935 Model M3536M6: US00554358 to US00576619
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide
Product Description
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 || Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Manufacturer
Philips Medical Systems, Inc.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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