GE OEC Medical Systems, Inc: OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.

Recall number

Z-1865-2012

Recalling firm

GE OEC Medical Systems, Inc

Product

OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.

Status

Terminated

Initiated

2006-11-20

Posted

2012-06-22

Terminated

2012-06-25

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.

Root cause

Software design

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.

Quantity

717 units

Distribution

Worldwide Distribution.

Lot, serial or model codes

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.

510(k) numbers

["K993687"]

PMA numbers

not on file

Product code

JAA

Firm FEI

1720753

Firm city

Salt Lake City

Firm state

UT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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