Device Recall OMNI

  • Model / Serial
    All units with Co-Oximetry (COOX) modules.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California, Florida, Georgia, Indiana, Iowa, New Hampshire, Michigan, New York, North Carolina, North Dakota, Pennsylvania, Texas and Washington.
  • Product Description
    Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA

21 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
  • Product Description
    OmniPod¿, Insulin Management System (US) || Catalog Number: PODZXP420 || Product Usage: || The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
  • Manufacturer
  • Model / Serial
    Lot Codes: L41908, L41910, F41935
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
  • Product Description
    OmniPod¿, Insulin Management System (OUS) || Catalog Number: 14810 || Product Usage: || The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
  • Manufacturer
  • Model / Serial
    OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan
  • Product Description
    OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
  • Manufacturer
  • Model / Serial
    Part No. CSF-40-12, Lot No. 132635
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.
  • Product Description
    Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System || The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture).
  • Manufacturer
  • Model / Serial
    OmniDiagnost User Interface PN 9896 000 59561, 9896 000 12381, 9896 000 58161;  The firm utilizes a ''site number'' specific to each unit: 101599, 103055, 103058, 100520, 100873, 101152, 101154, 101676, 101962, 102164, 102582, 102977, 103050, 103051, 103052, 103055, 103058, 103218, 103219, 104012, 104577, 104858, 104934, 105324, 105394, 13124, 38351, 50428, 76596, 76944, 76948, 82655, 83871, 83958, 84441, 84850, 85163, 85165, 86113, 86303, 86326, 86339, 86340, 86485, 86486, 86549, 86965, 86977, 87164, X1707, X1747, 104857
  • Product Classification
  • Distribution
    The firm distributed devices to 81 hospitals and medical centers located throughout the U.S.
  • Product Description
    OmniDiagnost System
  • Manufacturer
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