Device, Medical Examination, Ac Powered

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-02-20Open, ClassifiedUnder Investigation by firm

  MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light

  Due to battery component overheating while charging resulting in melting of internal components and causing smoke.

• 2013-08-21TerminatedProcess control

  Stryker Visum 300 Ceiling-mounted Exam Light.

  Potential incomplete final weld on the drop tube flange.

• 2004-07-20TerminatedComponent design/selection

  All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 Model 100580 SGL Trolley, Serial No.''s less than TRS962633 Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354.

  Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.

• TerminatedUnder Investigation by firm

  Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient observation during a medical examination. It increases ambient light to facilitate performance of procedures on the mattress field. It is designed to mount on the accessory railings of the Giraffe OmniBed, incubators and warmers except for Panda and Giraffe Warmers. It is not intended for use to support surgical field lighting.

  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 could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.

• TerminatedComponent design/selection

  Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated

  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 insufficient mount force that may cause the equipment to fall, resulting in serious injury.