OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imagi...
FDA Recall #Z-1865-2012 — Class II — November 20, 2006
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.
Reason for Recall
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.
Recalling Firm
GE OEC Medical Systems, Inc — Salt Lake City, UT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
717 units
Distribution
Worldwide Distribution.
Code Information
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.
Status
Terminated
Voluntary / Mandated
FDA Mandated