Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 25004 25005 25006 25007 28003 28004 31000 31001 31002 31003 31004 31005 31006 31008 31009 31011 31012 31013 31014 31015 31016 31017 31019 31020 31030 31039 31040 31041 31042 31043 31044 31045 31046 31047 31048 31050 31051 31052 31053 31054 31055 31056 38025 38026 38027 38028
  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: ARD568811961 Model: VLT600DF AIM STP

Product Codes/Lot Numbers:

Serial Numbers: 25004 25005 25006 25007 28003 28004 31000 31001 31002 31003 31004 31005 31006 31008 31009 31011 31012 31013 31014 31015 31016 31017 31019 31020 31030 31039 31040 31041 31042 31043 31044 31045 31046 31047 31048 31050 31051 31052 31053 31054 31055 31056 38025 38026 38027 38028

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1855-2019

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 →