Events

Device Recall OEC Uroview 2800 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE OEC Medical Systems, Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    62016
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1865-2012
  • 사례 시작날짜
    2006-11-20
  • 사례 출판 날짜
    2012-06-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-06-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109749
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    System, x-ray, fluoroscopic, image-intensified - Product Code JAA
  • 원인
    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.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution.
  • 제품 설명
    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
  • 제조사 주소
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA