Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 31000 31001 31002 31003 31004 31006 31008 31009 31010 31012 31017 31018 31019 31020 31021 31022 31023 31024 31025 31026 35000 35001 35011 35012 35013 35014 35015 35017 35018 35019 35020 35021 35022 35023 35024 35025 35026 35027 35028 35030 35031 35032 35033 38000 38001 38002 38003 38009 38011 38012 38013 38014 38015 38016 38018 38019 38020 38021 38022 38023 38025 38026 38027
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Maquet Cardiovascular Us Sales, Llc
Reason for Recall:
Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP

Product Codes/Lot Numbers:

Serial Numbers: 31000 31001 31002 31003 31004 31006 31008 31009 31010 31012 31017 31018 31019 31020 31021 31022 31023 31024 31025 31026 35000 35001 35011 35012 35013 35014 35015 35017 35018 35019 35020 35021 35022 35023 35024 35025 35026 35027 35028 35030 35031 35032 35033 38000 38001 38002 38003 38009 38011 38012 38013 38014 38015 38016 38018 38019 38020 38021 38022 38023 38025 38026 38027

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1854-2019

Related Recalls

The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of 1.8 mm between the two distinct and proximal areas on the printed circuit board (PCB) where as the standard requires a creepage distance of 4 mm.

Sep 30, 2020 Diagnostic Equipment Nationwide View Details →