Events

Recall of Device Recall OEC Uroview 2800

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE OEC Medical Systems, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62016
  • Event Risk Class
    Class 2
  • Event Number
    Z-1865-2012
  • Event Initiated Date
    2006-11-20
  • Event Date Posted
    2012-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109749
  • Notes / Alerts
    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, fluoroscopic, image-intensified - Product Code JAA
  • Reason
    Recalled in november 2006 due to several intermittent potential safety issues including navigation tracking inaccuracy, system lok-up, incorrect image display, incorrect dose area calculated air kerma in "film mode" and "digital spot mode", and the system does not reboot.
  • Action
    On 11/20/06 two written notifications were sent to consignees addressed to the Facility Administrator and the Radiology Administrator. The notifications advised them that GE Healthcare had identified several intermittent potential safety issues that may occur with the product. Interim solutions were provided for each issue. The letter stated that GEHC OEC would contact customers and remedy the issues free of charge when a permanent solution became available. An Urgent Recall Notice, dated April 13, 2007, was also sent to customers. Customers were to contact the service team at 800-874-7378 for further information, if there were any questions or concerns.

Device

Device Recall OEC Uroview 2800
  • Model / Serial
    All Serial Numbers: P4-0004-L , P4-0005-L , P4-0006-R-RC1 , P4-0008-R , P4-0011-L , P6-0654-R , P4-0012-R , P4-0013-L , P4-0014-L , P4-0015-L , P4-0016-L , P4-0017-L , P4-0018-L , P4-0019-R , P4-0020-L , P4-0021-L , P4-0022-R , P4-0023-L , P4-0024-R , P4-0025-R , P4-0026-L , P4-0027-R , P4-0028-R , P4-0029-R , P4-0030-R , P4-0031-L , P4-0680-L , P4-0032-R , P4-0033-R , P4-0034-R , P4-0035-R , P4-0036-R , P4-0037-R , P4-0038-L , P4-0039-R , P4-0042-R , P4-0044-L , P4-0045-R , P4-0046-L , P4-0047-L-RC , P4-0048-L , P4-0049-R , P4-0050-L , P4-0051-L , P4-0052-R , P4-0053-L , P4-0054-R , P4-0074-R , P4-0055-L , P4-0058-R , P4-0059-L , P4-0062-L , P4-0064-L , P4-0067-L , P4-0075-L , P4-0068-R , P4-0070-L , P4-0071-L , P4-0073-R , P4-0076-R , P4-0078-R , P4-0081-L , P4-0082-R , P4-0388-L , P4-0084-R , P4-0085-R , P4-0087-R , P4-0088-L , P4-0089-L , P4-0090-L , P4-0092-R , P4-0093-R , P4-0094-R , P4-0095-R , P4-0097-R , P4-0098-R , P4-0099-L , P4-0100-R , P4-0101-R , P4-0102-R , P4-0103-R , P4-0104-R , P4-0105-R , P4-0107-L , P4-0108-R , P4-0110-L , P4-0111-L , P4-0112-L , P4-0113-R , P4-0114-L , P4-0661-L , P4-0115-R , P4-0117-R , P4-0118-R , P4-0119-L , P4-0120-L , P4-0121-L , P4-0123-L , P4-0124-R , P4-0127-L , P4-0128-R , P4-0131-R , P4-0132-R , P4-0133-L , P4-0138-R , P4-0140-L , P4-0141-R , P4-0142-R, P4-0154-R , P4-0696-L , P4-0143-L , P4-0146-R , P4-0147-L , P4-0149-R , P4-0211-R , P4-0151-L , P4-0153-R , P4-0155-R , P4-0159-L , P4-0160-L , P4-0161-L , P4-0162-R , P4-0163-R , P6-0529-L , P4-0164-R , P4-0165-L , P4-0167-R , P4-0168-R , P4-0169-R , P4-0170-R , P4-0172-R , P4-0175-L , P4-0176-L , P4-0177-R , P4-0178-R , P4-0179-L , P4-0181-L , P4-0183-R , P4-0185-R , P4-0301-R , P4-0187-L , P4-0188-L , P4-0190-R , P4-0191-L , P4-0194-L , P4-0195-R , P4-0196-L , P4-0197-L , P4-0199-R , P4-0201-R , P4-0202-R , P4-0203-L , P4-0204-R , P4-0205-R , P4-0206-L , P4-0209-L , P4-0212-L , P4-0215-L , P4-0216-R , P4-0223-R , P4-0232-L , P4-0237-R , P4-0238-L , P4-0239-R , P4-0240-L , P4-0241-L , P4-0242-R , P4-0244-R , P4-0246-R , P4-0247-R , P4-0248-R , P4-0451-L , P4-0254-L , P4-0255-R , P4-0256-R , P4-0257-L , P4-0258-L , P4-0259-L , P4-0445-L , P4-0260-R , P4-0263-L , P4-0264-R , P4-0268-R , P4-0659-R , P4-0269-R , P4-0271-R , P4-0273-L , P6-0715-L , P4-0274-R , P4-0277-L , P4-0279-R , P4-0685-L , P4-0280-R , P4-0282-L , P4-0281-L , P4-0284-L , P4-0285-L , P4-0288-R , P4-0289-L , P4-0292-L , P4-0293-R , P4-0294-L , P4-0296-R , P4-0297-R , P4-0298-R , P4-0299-L , P4-0300-R , P4-0318-L , P4-0302-L , P4-0304-R , P4-0305-L , P4-0306-R , P4-0308-L , P4-0309-R , P4-0310-L , P4-0313-L , P4-0315-L , P4-0316-R , P4-0457-R , P4-0319-R , P4-0321-L , P4-0322-L , P4-0325-R , P4-0326-R , P4-0327-L , P4-0328-R , P4-0329-L , P4-0332-L , P4-0333-R , P4-0335-R , P4-0339-L , P4-0340-R , P4-0341-R , P4-0342-L , P4-0343-L , P4-0345-R , P4-0346-L , P4-0347-L , P4-0348-R , P4-0349-L , P4-0353-L , P4-0354-R , P4-0355-L , P4-0356-L , P4-0359-R , P4-0361-R , P4-0362-R , P4-0365-R , P4-0367-R , P4-0370-L , P4-0373-R , P4-0377-L , P4-0380-L , P4-0381-L , P4-0382-R , P4-0385-R , P4-0386-R , P4-0389-L , P4-0391-L , P4-0393-R , P4-0394-R , P4-0401-R , P4-0402-R , P4-0405-L , P4-0406-L , P4-0407-R , P4-0408-R , P4-0409-R , P4-0410-R , P4-0411-L , P4-0413-L , P4-0416-R , P4-0415-L , P4-0417-R , P4-0418-L-RC , P4-0419-L , P4-0422-L , P4-0424-R , P4-0425-R , P4-0426-L , P4-0428-R , P4-0431-R , P4-0436-R , P4-0440-R , P4-0442-L , P6-0472-R , P4-0443-R , P4-0444-R , P4-0446-R , P4-0447-L , P4-0448-L , P4-0449-L , P4-0450-L , P4-0452-L , P4-0453-R , P4-0454-L , P4-0455-L , P4-0456-R , P4-0459-R , P4-0460-R , P4-0463-L , P4-0464-L , P4-0465-R , P4-0466-R , P4-0467-L , P4-0469-R , P4-0471-R , P4-0473-R , P4-0477-L , P4-0478-L , P4-0482-R , P4-0483-L , P4-0487-R , P4-0489-L , P4-0491-L , P4-0492-L , P4-0495-L , P4-0496-L , P4-0498-L , P4-0500-L , P4-0503-R , P4-0504-L , P4-0505-L , P4-0506-R , P4-0507-R , P4-0508-L , P4-0511-R , P4-0517-L , P4-0523-R , P4-0524-L , P4-0531-R , P4-0532-R , P4-0537-L , P4-0539-L , P4-0540-L , P4-0541-L , P4-0545-L , P4-0548-L , P4-0550-L , P4-0551-L , P4-0560-R , P4-0561-L , P4-0566-L , P4-0569-R , P4-0570-R , P4-0573-R , P4-0574-R , P4-0575-L , P4-0576-L , P4-0581-R , P4-0588-R , P4-0589-L , P4-0590-R , P4-0591-R , P4-0592-R , P4-0594-L , P4-0595-L , P4-0596-L , P4-0597-R , P4-0602-L , P4-0603-R , P4-0605-R , P4-0607-L , P4-0608-R , P4-0611-L , P4-0613-R , P4-0615-L , P4-0616-R , P4-0626-R , P4-0628-L , P4-0631-L , P4-0633-L , P4-0636-R , P4-0637-R , P4-0638-R , P4-0639-R , P4-0640-R , P4-0641-R , P4-0642-R , P4-0644-L , P4-0645-R , P4-0648-L , P4-0650-L , P4-0652-L , P4-0653-L , P4-0655-R , P4-0656-R , P4-0657-L , P6-0598-L , P4-0662-L , P4-0666-L , P4-0668-R , P4-0669-R , P4-0670-R , P4-0679-R , P4-0686-L , P4-0694-R , P4-0701-R , P4-0702-R , P4-0717-L , P4-0723-R , P4-0730-L , P6-0040-R , P6-0043-R, P6-0214-R, P6-0219-L, P6-0220-L, P6-0221-R, P6-0222-R,P6-0225-R, P6-0227-R, P6-0230-L, P6-0249-R, P6-0251-L, P6-0252-L , P6-0253 , P6-0056-L , P6-0061-L-RC , P6-0066-R , P6-0069-R , P6-0072-R , P6-0077-R , P6-0079-L , P6-0080-L , P6-0083-L , P6-0091-R , P6-0096-R , P6-0106-R , P6-0109-L , P6-0116-R , P6-0122-L , P6-0125-R , P6-0126-L , P6-0582-L , P6-0129-R , P6-0130-R , P6-0134-R, P6-0144-L , P6-0182-L , P6-0135-L , P6-0136-R , P6-0137-R , P6-0139-R , P6-0145-L , P6-0148-R-RC , P6-0150-L , P6-0152-L , P6-0156-L , P6-0157-R , P6-0166-L , P6-0171-L , P6-0184-L , P6-0186-R , P6-0192-L , P6-0193-R , P6-0198-L , P6-0200-R , P6-0210-L , P6-0213-L , P6-0218-R , P6-0226-R , P6-0228-R , P6-0229-R , P6-0231-L , P6-0233-L , P6-0234-R , P6-0235-R , P6-0699-R , P6-0236-R , P6-0243-L , P6-0245-L , P6-0250-R , P6-0261-R , P6-0262-R , P6-0265-L , P6-0267-R , P6-0270-L-RC , P6-0709-R , P6-0275-L , P6-0276-L , P6-0278-R , P6-0283-R , P6-0286-R , P6-0287-L , P6-0290-R , P6-0291-L , P6-0295-R , P6-0303-L , P6-0307-L , P6-0311-R , P6-0312-L , P6-0314-L , P6-0317-R , P6-0320-R , P6-0324-R , P6-0330-L , P6-0336-L , P6-0338-L , P6-0344-R , P6-0351-L , P6-0704-L , P6-0352-R , P6-0358-R , P6-0360-L , P6-0363-L , P6-0364-L , P6-0366-R , P6-0371-R , P6-0372-R , P6-0375-L , P6-0378-L , P6-0383-R , P6-0387-L , P6-0392-R , P6-0397-L , P6-0398-L , P6-0399-L , P6-0412-R , P6-0414-R , P6-0420-R , P6-0421-R , P6-0423-R , P6-0427-L , P6-0432-R , P6-0435-R , P6-0437-R , P6-0438-R , P6-0439-L , P6-0461-L , P6-0462-R , P6-0468-L , P6-0470-R , P6-0479-R , P6-0480-R , P6-0486-R , P6-0493-R , P6-0494-R , P6-0497-R , P6-0499-R , P6-0502-R , P6-0522-R , P6-0509-L , P6-0510-L , P6-0512-L , P6-0513-R , P6-0514-R , P6-0515-L , P6-0516-R , P6-0518-R , P6-0519-R , P6-0520-L , P6-0521-R , P6-0530-R , P6-0533-L , P6-0534-L , P6-0538-R , P6-0542-R , P6-0543-R , P6-0544-R , P6-0546-L , P6-0549-R , P6-0552-L , P6-0553-R , P6-0554-R , P6-0555-L , P6-0558-L , P6-0559-L , P6-0562-R , P6-0563-R , P6-0564-R , P6-0565-R , P6-0567-R , P6-0571-L , P6-0572-L , P6-0577-R , P6-0578-R , P6-0579-R , P6-0583-R , P6-0584-R , P6-0585-L , P6-0586-L , P6-0587-L , P6-0599-L , P6-0600-R , P6-0612-R , P6-0614-L , P6-0617-L , P6-0618-R , P6-0619-L , P6-0620-L , P6-0621-R , P6-0622-L , P6-0623-R , P6-0624-L , P6-0625-R , P6-0627-L , P6-0629-L , P6-0632-R , P6-0634-R , P6-0635-L , P6-0643-R , P6-0646-L , P6-0647-R , P6-0658-R , P6-0660-R , P6-0663-R , P6-0672-L , P6-0674-L , P6-0676-L , P6-0677-L , P6-0682-L , P6-0683-L , P6-0687-L , P6-0688-R , P6-0689-R , P6-0690-L , P6-0691-L , P6-0692-L , P6-0693-L , P6-0695-R , P6-0698-L , P6-0700-R , P6-0703-L , P6-0705-L , P6-0706-L , P6-0708-R , P6-0710-L , P6-0712-R , P6-0713-R , P6-0714-L , P6-0716-R , P6-0720-R , P6-0718-R , P6-0719-L , P6-0721-L , P6-0724-R , P6-0726-L , P4-0007-R-RC , P6-0009-L, and P4-0481-L.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    OEC Uroview 2800, Model number A349855. || Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA