Maquet Surgical Light Suspension Arms Recalled for Debris Risk
Maquet is recalling 646 PowerLED, X-TEN, and VOLISTA surgical light systems because suspension arms may grind and release paint chips into the surgical field.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (foreign object contamination in a surgical field) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 646 PowerLED, X-TEN, and VOLISTA surgical light systems. These devices are intended to provide visible illumination of the surgical area or patient and are typically mounted on ceilings with rotating arms.
The recall is due to a defect where the suspension arms may grind at the junction. This grinding can cause paint chips or particles to fall into the surgical field when the arms are mounted above the surgical table.
The affected units were distributed worldwide, including in the United States and numerous international countries. Specific part numbers and serial numbers are listed in the official recall documentation. Users should contact Maquet Cardiovascular US Sales, LLC for instructions on how to address this issue.
The recalled product
- Product
- The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Affected units
- 646
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Dual Arm: Part #569710902 - Serial Numbers: 15664
- 15672 thru 15673
- 15738 thru 15739
- 15791
- 15803
- 15818 thru 15819
- 15822 thru 15823
- 15830
- 15834 thru 15835
- 15881
- 15889
- 15981
- 16016
- 16019
- 16058 thru 16064
- 16066 thru 16067
- 16120
- 16284
- 16286 thru 16287
- 20076 thru 20077
Distribution
Distributed nationwide across the United States.
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