Reported Jun 18, 2014 · Terminated

Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.

Maquet Medical Systems USA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Maquet Medical Systems USA · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094

Is this the product you have?

Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.

Lot codes and dates: Part number (begins
with ALM) and associated serial numbers
751 of 751 codes
ALM568300999 13
14
16
19
20
21
22
23
24
25
29
30
31
32
34
35
36
41
50 ALM568301999 13
14
16
17
20
23
24
25
26
52
54
55
56
57
60
63
64
65
66
70
71
72
74 ALM568302999 11
43
44
46
49
50
51
54
57
58
59
6
61
63
64
66
67
71
72
74
Amount recalled: United States 1169 units

Where it was sold

Nationwide

Why it was recalled

Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). One or several plastic fixation tabs can break, which can cause the ambient light module to partially detach.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Medical device recalls

Other recalls from Maquet Medical Systems USA

15 in total.

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