High FDA (Devices)·Z-1730-2014·Announced 2014-06-18

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.

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 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
Category: Medical Device — Surgical Lighting
Hazard: component-detachment
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.

Same manufacturer · Maquet Medical Systems USA

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Same hazard · component detachment