Device Recall GEHealthcare, Drapes and Sterile Covers

  • 모델명 / 제조번호(시리얼번호)
    all codes
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Canada, Australia, Bahamas, China, Hong Kong, Italy, Japan, Korea, Mexico, Malaysia, Singapore, and El Salvador.
  • 제품 설명
    GE Healthcare, Drapes and Sterile Covers || PART NUMBER DESCRIPTION || 00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL || 00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AND HOSE 2000,2500 || 00-900352-02 STRL, BAG, DRAIN WITH METAL TABS || 00-900493-03 COVER DISPOSABLE X-RAY TUBE || 00-900605-01 UROFAST DRAIN BAG (UROFAST ONLY) || 00-900605-01-OEC STRL, BAG, DRAIN, WITH HOSE, UROFAST || 00-900885-01 URO2600 DRAIN BAG 2.0 PE MATERIAL || 00-900885-01-OEC STRL, BAG, DRAIN, URO2600 || 00-900943-01 STRL, COVER, CARM, HALF BAG, 36X80, 90,94,76 || 00-900974-01 STRL, DRAPING, MINI-CARM, KYBRD, BLK FTSW, 6600 || 00-901072-01 URO 2600 DISPOSABLES PACK 2.0 PE MATERIAL || 00-901072-01-OEC STRL, PACK, DISPOSABLES, UROVIEW 2600 || 00-901169-01 12 TUBE DRAPE (36X36) 2.0 PE MATERIAL || 00-901169-01-OEC STRL, COVER, DISPOSABLE, 12 INCH TUBE 9600 || 00-901268-01 DRAPE,STERIQUIK, STANDARD&SUPER-; || C,9600/7700 || 00-901390-01 STRL, DRAPING, KEYBOARD, FOOTSWITCH, 20PACK, 6600 || 00-901391-01 STRL, DRAPE, C-ARM ONLY, 6600 || 00-901392-01 STRL, COVER, KEYBOARD, 66,68 || 00-901501-01 9600/9800/SUPER C DISPOSABLES PACK 2.0 PE MATERIAL || 00-901501-01-OEC STRL, PACK, DISPOSABLES, MODEL 9800, 20 PACK || 00-901581-01-OEC STRL, COVER, DISPOSABLE, IR REMOTE, 9600, 9800 || 00901588-01 12 C ARM DISPOSABLES PACK 2.0 PE MATERIAL || 00-901588-01-OEC STRL, PACK, DISPOSABLES, 12 INCH, 20 PACK SCD 9600 || 00-901761-01 STRL, DISPOSABLES PACK, UROVIEW 2800 || 00-901831-02 STRL, COVER, FLUOROTRAK MONITOR, || DISPOSABLE BOX 10 PER PKG || 00-901832-01 STRL, APIX, COVER, DISPOSABLE CONTROLPANEL COVERS, REPLACEMENT PART CASE OF 25 || 00-901917-01 STRL, DRAPE, C-ARM, 6800 || 00-901918-01 MINIVIEW 6800 C-ARM CONSUMABLES PACK GRAY FOOTSWITCH || 00-901918-01-OEC STRL, DRAPE, 20 PACK, 6800 || 00-902752-01 STRL, RUI COVERS 25 COVERS || 00-902753-01 STRL, PACK, DISPOSABLE, 9800MD, 9 INCH 20 PACKS || 00-902754-01 STRL, PACK, DISPOSABLE, 9800MD, 12 INCH 20 PACKS || 00-902776-01 STRL, DRAPE, VASCULAR || 00-902864-01 STRL, DRAPE, HALF, C ARM, 9800 9600 || 00-902934-01 STRL, DRAPE, WORKSTATION, 20 PER BOX, 9900 || 1003135 STRL, BAG, FLAT PANEL || E7009AE STRL, DRAPE, AFM/CFM PEDESTAL, 25 PER BOX || E7009AF STRL, DRAPE, AFM/CFM JOYSTICK, 50 PER BOX || E7009AG STRL, DRAPE, LARGE DOME BAG, 20 PER BOX || E7009AH STRL, DRAPE, MEDIUM DOME BAG, 20 PER BOX || E7009AJ STRL, DRAPE, SMALL DOME BAG, 20 PER BOX || Sterile EO, Distributed by GE Medical Systems, Milwaukee, WI 53201, Manufactured by Contour Fabricators, Inc. Fenton, MI 48430. || The disposable sterile product provide a sterile barrier between the imaging device and sterile surgical field.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA