SOLED15
ACEM SPA · Model SOLED15 /SC1 · UDI-DI 08050705890293
KZF
Prescription
10
510(k) clearances
401
Adverse events
5
Recalls
92
Facilities
Description
SOLED15 1-ARM CEILING STANDARD LINE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-13 | MRIMed Inc. | Due to battery component overheating while charging resulting in melting of internal components and causing smoke. |
| 2017-04-21 | Stryker Communications | The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be in |
| 2016-11-18 | Ohmeda Medical | Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord |
| 2013-07-25 | Stryker Communications | Potential incomplete final weld on the drop tube flange. |
| 2004-02-19 | Burton Medical Products Corp | Pivot joint on these ceiling mount lights may fail and lights may fall onto patients. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.