Maquet PowerLED 700 Surgical Light Recall Due to Detaching Module
Maquet is recalling PowerLED 700 surgical lights because plastic tabs may break, causing the ambient light module to partially detach.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II. The hazard involves a component detaching from a surgical device, which presents a risk of harm in a clinical setting, but no injuries or illnesses are reported in the source text.
Plain-English summary
Maquet Medical Systems USA is recalling specific units of the Maquet PowerLED 700 surgical light. The recall affects 1,169 units distributed nationwide in the United States.
The recall was initiated because one or several plastic fixation tabs on the device can break. This defect can cause the ambient light module to partially detach from the main unit.
Hospitals and surgical facilities should check their inventory against the specific part numbers and serial numbers listed in the official FDA recall notice Z-1730-2014. Affected units should be removed from service and returned to Maquet for repair or replacement.
The recalled product
- Product
- Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- Affected units
- 1,169
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)
- Part number (begins with ALM) and associated serial numbers: ALM568300999 13
- 14
- 16
- 19
- 20
- 21
- 22
- 23
- 24
- 25
- 29
- 30
- 31
- 32
- 34
- 35
- 36
- 41
- 50 ALM568301999 13
- 17
Distribution
Distributed nationwide across the United States.
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