Food, drugs, devices › Maquet Medical Systems USA
Device recall: Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.
Maquet Medical Systems USA (Wayne, NJ) initiated this device recall on 16 Apr 2014; FDA lists 1 product record under event 68142, classified Class II.
FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 6 Apr 2016. Initiation: voluntary: firm initiated. Maquet Medical Systems USA has 20 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Maquet Medical Systems USA, Wayne, NJ.
Reason for recall
"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."
Distribution
"US Nationwide Distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1730-2014 | Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient. | United States 1169 units | Class II | Terminated | 18 Jun 2014 |
Context
Other enforcement events for Maquet Medical Systems USA
All 20 events for Maquet Medical Systems USA
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Apr 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.