Drugs & medicalClass II

Getinge Usa Sales Inc recalls Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C,…

A potential for a light system to fall in the operating room.

Read the official notice →
Date
2024-01-24
Country
United States
Brand
Getinge Usa Sales
Product
Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C,…
Classification
Class II
Units
US Nationwide. Global Distribution.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Getinge Usa Sales recalls

  1. 2024-07-17
  2. US
    Drugs & medicalClass II

    Getinge Usa Sales Inc recalls ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4

    The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a risk of inadequate charging and operational…

    FDA · DeviceGetinge Usa Sales IncDomestic: KY, NC, NY, VA. International: Australia, Bulgaria, Croatia, Czech…Official notice →
  3. 2024-06-12
  4. US
    Drugs & medicalClass I

    Getinge Usa Sales Inc recalls Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.

    Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of…

    FDA · DeviceGetinge Usa Sales IncDomestic: CA, CO, IN, MO, OR, VA, WA. International: Aruba, Australia,…Official notice →
  5. 2024-02-14
  6. US
    Drugs & medicalClass II

    Getinge Usa Sales Inc recalls Flow-c Anesthesia System, model 6887700

    Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous…

    FDA · DeviceGetinge Usa Sales IncWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO,…Official notice →
  7. 2023-10-11
  8. US
    Drugs & medicalClass II

    Getinge Usa Sales Inc recalls Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as…

    Under certain conditions, an issue might prevent the device from performing as intended. A specific sequence of commands on the control unit activates the traction drive and triggers an unintended driving (autodrive)…

    FDA · DeviceGetinge Usa Sales IncUS Nationwide distribution.Official notice →
  9. 2023-02-01
  10. US
    Drugs & medicalClass I

    Getinge Usa Sales Inc recalls Getinge Flow-e Anesthesia System, Part No. 6887900

    Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered O2 concentration may lead to hypoventilation and…

    FDA · DeviceGetinge Usa Sales IncUS nationwide and Worldwide Distribution: Domestic distribution to AL, AR, AZ,…Official notice →
  11. 2022-12-14
  12. US
    Drugs & medicalClass II

    Getinge Usa Sales Inc recalls Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)

    The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the expected run time in the event of a mains power…

    FDA · DeviceGetinge Usa Sales IncUS Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.Official notice →
All 17 Getinge Usa Sales recalls →

Other drugs & medical recalls in the United States

  1. 2024-01-31
  2. US
    Drugs & medicalClass II

    Glenmark Pharmaceuticals Inc., USA recalls Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark…

    Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

    FDA · DrugGlenmark Pharmaceuticals Inc., USAUSA NationwideOfficial notice →
  3. US
  4. US
    Drugs & medicalClass III

    Amerisource Health Services LLC recalls Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health…

    Superpotent drug: Assay results were slightly above specification at the time zero point.

    FDA · DrugAmerisource Health Services LLCNationwide in the USAOfficial notice →
  5. 2024-01-24
  6. US
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    Cardinal Health 200, LLC recalls CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510

    The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard…

    FDA · DeviceCardinal Health 200, LLCUS, Canada, Australia and New ZealandOfficial notice →
  7. US
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    Randox Laboratories Ltd. recalls Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351

    Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples

    FDA · DeviceRandox Laboratories Ltd.US Nationwide including Puerto Rico.Official notice →
  8. US
    Drugs & medicalClass II

    Randox Laboratories Ltd. recalls Calibration Serum Level 3 CAL2351

    CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.

    FDA · DeviceRandox Laboratories Ltd.US Nationwide and Puerto Rico.Official notice →
See all drugs & medical recalls →