PlainRecalls
FDA Devices Moderate Class II Ongoing

Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A, PWDII755SF - ARDPWT629104A, PWDII775DF - ARDPWT629105A, PWDII775SF - ARDPWT629106A, PWDII50DF - ARDPWT629109A, PWDII50SF - ARDPWT629110A, PWDII50SF - ARDPWT629111A, PWDII55DF - ARDPWT629112A, PWDII55SF - ARDPWT629113A, PWDII70DF - ARDPWT629114A, PWDII70DF - ARDPWT629115A, PWDII70SF - ARDPWT629116A, PWDII70SF - ARDPWT6291

Reported: January 24, 2024 Initiated: November 8, 2023 #Z-0757-2024

Product Description

Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A, PWDII755SF - ARDPWT629104A, PWDII775DF - ARDPWT629105A, PWDII775SF - ARDPWT629106A, PWDII50DF - ARDPWT629109A, PWDII50SF - ARDPWT629110A, PWDII50SF - ARDPWT629111A, PWDII55DF - ARDPWT629112A, PWDII55SF - ARDPWT629113A, PWDII70DF - ARDPWT629114A, PWDII70DF - ARDPWT629115A, PWDII70SF - ARDPWT629116A, PWDII70SF - ARDPWT629117A, PWDII75DF - ARDPWT629118A, PWDII75SF - ARDPWT629119A, PWDII50DF - ARDPWT629120A, PWDII50SF - ARDPWT629121A, PWDII50SF - ARDPWT629122A, PWDII55DF - ARDPWT629123A, PWDII55SF - ARDPWT629124A, PWDII70DF - ARDPWT629125A, PWDII70DF - ARDPWT629126A, PWDII70SF - ARDPWT629127A, PWDII70SF - ARDPWT629128A, PWDII75DF - ARDPWT629129A, PWDII75SF - ARDPWT629130A, PWDII50DF - ARDPWT629131A, PWDII50SF - ARDPWT629132A, PWDII50SF - ARDPWT629133A, PWDII55DF - ARDPWT629134A, PWDII55SF - ARDPWT629135A, PWDII70DF - ARDPWT629136A, PWDII70DF - ARDPWT629137A, PWDII70SF - ARDPWT629138A, PWDII70SF - ARDPWT629139A, PWDII75DF - ARDPWT629140A, PWDII75SF - ARDPWT629141A, PWDII50DF - ARDPWT629142A, PWDII50SF - ARDPWT629143A, PWDII50SF - ARDPWT629144A, PWDII55DF - ARDPWT629145A, PWDII55SF - ARDPWT629146A, PWDII70DF - ARDPWT629147A, PWDII70DF - ARDPWT629148A, PWDII70SF - ARDPWT629149A, PWDII70SF - ARDPWT629150A, PWDII75DF - ARDPWT629151A, PWDII75SF - ARDPWT629152A, PWDII50DF - ARDPWT629154A, PWDII50DF - ARDPWT629155A, PWDII77SF - ARDPWT629156A, PWDII50DF - ARDPWT639001A, PWDII50DF - ARDPWT639002A, PWDII50DF - ARDPWT639003A, PWDII50DF - ARDPWT639004A, PWDII50SF - ARDPWT639006A, PWDII50SF - ARDPWT639007A, PWDII50SF - ARDPWT639008A, PWDII50SF - ARDPWT639009A, PWDII70DF - ARDPWT639011A, PWDII70DF - ARDPWT639012A, PWDII70DF - ARDPWT639013A, PWDII70DF - ARDPWT639014A, PWDII70SF - ARDPWT639016A, PWDII70SF - ARDPWT639017A, PWDII70SF - ARDPWT639018A, PWDII70SF - ARDPWT639019A, PWDII70DF - ARDPWT639021A, PWDII50DF - ARDPWT639022A, PWDII50DF - ARDPWT639023A, PWDII50DF - ARDPWT639024A, PWDII50DF - ARDPWT639025A, PWDII50SF - ARDPWT639027A, PWDII50SF - ARDPWT639028A, PWDII50SF - ARDPWT639029A, PWDII50SF - ARDPWT639030A, PWDII70DF - ARDPWT639032A, PWDII70DF - ARDPWT639033A, PWDII70DF - ARDPWT639034A, PWDII70DF - ARDPWT639035A, PWDII70SF - ARDPWT639037A, PWDII70SF - ARDPWT639038A, PWDII70SF - ARDPWT639039A, PWDII70SF - ARDPWT639040A, PWDII70DF - ARDPWT639042A, PWDII50DF - ARDPWT639043A, PWDII50DF - ARDPWT639044A, PWDII50DF - ARDPWT639045A, PWDII50DF - ARDPWT639046A, PWDII55DF - ARDPWT639048A, PWDII55DF - ARDPWT639049A, PWDII55DF - ARDPWT639050A, PWDII75DF - ARDPWT639052A, PWDII75DF - ARDPWT639053A, PWDII75DF - ARDPWT639054A, PWDII50SF - ARDPWT639056A, PWDII50SF - ARDPWT639057A, PWDII50SF - ARDPWT639058A, PWDII50SF - ARDPWT639059A, PWDII55DF - ARDPWT639061A, PWDII55DF - ARDPWT639063A, PWDII55SF - ARDPWT639064A, PWDII55SF - ARDPWT639066A, PWDII55SF - ARDPWT639067A, PWDII55SF - ARDPWT639068A, PWDII55SF - ARDPWT639069A, PWDII70DF - ARDPWT639071A, PWDII70DF - ARDPWT639072A, PWDII70DF - ARDPWT639073A, PWDII70DF - ARDPWT639074A, PWDII70DF - ARDPWT639076A, PWDII70SF - ARDPWT639077A, PWDII70SF - ARDPWT639078A, PWDII70SF - ARDPWT639079A, PWDII70SF - ARDPWT639080A, PWDII75DF - ARDPWT639082A, PWDII75DF - ARDPWT639084A, PWDII75SF - ARDPWT639086A, PWDII75SF - ARDPWT639088A, PWDII75SF - ARDPWT639089A, PWDII75SF - ARDPWT639090A, PWDII75SF - ARDPWT639091A, PWDII77DF - ARDPWT639093A, PWDII77DF - ARDPWT639095A, PWDII77DF - ARDPWT639096A, PWDII77DF - ARDPWT639098A, PWDII77DF - ARDPWT639099A, PWDII77SF - ARDPWT639101A, PWDII77SF - ARDPWT639103A, PWDII77SF - ARDPWT639104A, PWDII77SF - ARDPWT639105A, PWDII77SF - ARDPWT639106A, PWDII50DF - ARDPWT639108A, PWDII50DF - ARDPWT639109A, PWDII50DF - ARDPWT639110A, PWDII50DF - ARDPWT639111A, PWDII55DF - ARDPWT639113A, PWDII55DF - ARDPWT639114A, PWDII55DF - ARDPWT639115A, PWDII75DF - ARDPWT639117A, PWDII75DF - ARDPWT639118A, PWDII75DF - ARDPWT639119A, PWDII50SF -

Reason for Recall

A potential for a light system to fall in the operating room.

Details

Recalling Firm
Getinge Usa Sales Inc
Units Affected
236793 units in total
Distribution
US Nationwide. Global Distribution.
Location
Wayne, NJ

Frequently Asked Questions

What product was recalled? ▼
Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A, PWDII755SF - ARDPWT629104A, PWDII775DF - ARDPWT629105A, PWDII775SF - ARDPWT629106A, PWDII50DF - ARDPWT629109A, PWDII50SF - ARDPWT629110A, PWDII50SF - ARDPWT629111A, PWDII55DF - ARDPWT629112A, PWDII55SF - ARDPWT629113A, PWDII70DF - ARDPWT629114A, PWDII70DF - ARDPWT629115A, PWDII70SF - ARDPWT629116A, PWDII70SF - ARDPWT629117A, PWDII75DF - ARDPWT629118A, PWDII75SF - ARDPWT629119A, PWDII50DF - ARDPWT629120A, PWDII50SF - ARDPWT629121A, PWDII50SF - ARDPWT629122A, PWDII55DF - ARDPWT629123A, PWDII55SF - ARDPWT629124A, PWDII70DF - ARDPWT629125A, PWDII70DF - ARDPWT629126A, PWDII70SF - ARDPWT629127A, PWDII70SF - ARDPWT629128A, PWDII75DF - ARDPWT629129A, PWDII75SF - ARDPWT629130A, PWDII50DF - ARDPWT629131A, PWDII50SF - ARDPWT629132A, PWDII50SF - ARDPWT629133A, PWDII55DF - ARDPWT629134A, PWDII55SF - ARDPWT629135A, PWDII70DF - ARDPWT629136A, PWDII70DF - ARDPWT629137A, PWDII70SF - ARDPWT629138A, PWDII70SF - ARDPWT629139A, PWDII75DF - ARDPWT629140A, PWDII75SF - ARDPWT629141A, PWDII50DF - ARDPWT629142A, PWDII50SF - ARDPWT629143A, PWDII50SF - ARDPWT629144A, PWDII55DF - ARDPWT629145A, PWDII55SF - ARDPWT629146A, PWDII70DF - ARDPWT629147A, PWDII70DF - ARDPWT629148A, PWDII70SF - ARDPWT629149A, PWDII70SF - ARDPWT629150A, PWDII75DF - ARDPWT629151A, PWDII75SF - ARDPWT629152A, PWDII50DF - ARDPWT629154A, PWDII50DF - ARDPWT629155A, PWDII77SF - ARDPWT629156A, PWDII50DF - ARDPWT639001A, PWDII50DF - ARDPWT639002A, PWDII50DF - ARDPWT639003A, PWDII50DF - ARDPWT639004A, PWDII50SF - ARDPWT639006A, PWDII50SF - ARDPWT639007A, PWDII50SF - ARDPWT639008A, PWDII50SF - ARDPWT639009A, PWDII70DF - ARDPWT639011A, PWDII70DF - ARDPWT639012A, PWDII70DF - ARDPWT639013A, PWDII70DF - ARDPWT639014A, PWDII70SF - ARDPWT639016A, PWDII70SF - ARDPWT639017A, PWDII70SF - ARDPWT639018A, PWDII70SF - ARDPWT639019A, PWDII70DF - ARDPWT639021A, PWDII50DF - ARDPWT639022A, PWDII50DF - ARDPWT639023A, PWDII50DF - ARDPWT639024A, PWDII50DF - ARDPWT639025A, PWDII50SF - ARDPWT639027A, PWDII50SF - ARDPWT639028A, PWDII50SF - ARDPWT639029A, PWDII50SF - ARDPWT639030A, PWDII70DF - ARDPWT639032A, PWDII70DF - ARDPWT639033A, PWDII70DF - ARDPWT639034A, PWDII70DF - ARDPWT639035A, PWDII70SF - ARDPWT639037A, PWDII70SF - ARDPWT639038A, PWDII70SF - ARDPWT639039A, PWDII70SF - ARDPWT639040A, PWDII70DF - ARDPWT639042A, PWDII50DF - ARDPWT639043A, PWDII50DF - ARDPWT639044A, PWDII50DF - ARDPWT639045A, PWDII50DF - ARDPWT639046A, PWDII55DF - ARDPWT639048A, PWDII55DF - ARDPWT639049A, PWDII55DF - ARDPWT639050A, PWDII75DF - ARDPWT639052A, PWDII75DF - ARDPWT639053A, PWDII75DF - ARDPWT639054A, PWDII50SF - ARDPWT639056A, PWDII50SF - ARDPWT639057A, PWDII50SF - ARDPWT639058A, PWDII50SF - ARDPWT639059A, PWDII55DF - ARDPWT639061A, PWDII55DF - ARDPWT639063A, PWDII55SF - ARDPWT639064A, PWDII55SF - ARDPWT639066A, PWDII55SF - ARDPWT639067A, PWDII55SF - ARDPWT639068A, PWDII55SF - ARDPWT639069A, PWDII70DF - ARDPWT639071A, PWDII70DF - ARDPWT639072A, PWDII70DF - ARDPWT639073A, PWDII70DF - ARDPWT639074A, PWDII70DF - ARDPWT639076A, PWDII70SF - ARDPWT639077A, PWDII70SF - ARDPWT639078A, PWDII70SF - ARDPWT639079A, PWDII70SF - ARDPWT639080A, PWDII75DF - ARDPWT639082A, PWDII75DF - ARDPWT639084A, PWDII75SF - ARDPWT639086A, PWDII75SF - ARDPWT639088A, PWDII75SF - ARDPWT639089A, PWDII75SF - ARDPWT639090A, PWDII75SF - ARDPWT639091A, PWDII77DF - ARDPWT639093A, PWDII77DF - ARDPWT639095A, PWDII77DF - ARDPWT639096A, PWDII77DF - ARDPWT639098A, PWDII77DF - ARDPWT639099A, PWDII77SF - ARDPWT639101A, PWDII77SF - ARDPWT639103A, PWDII77SF - ARDPWT639104A, PWDII77SF - ARDPWT639105A, PWDII77SF - ARDPWT639106A, PWDII50DF - ARDPWT639108A, PWDII50DF - ARDPWT639109A, PWDII50DF - ARDPWT639110A, PWDII50DF - ARDPWT639111A, PWDII55DF - ARDPWT639113A, PWDII55DF - ARDPWT639114A, PWDII55DF - ARDPWT639115A, PWDII75DF - ARDPWT639117A, PWDII75DF - ARDPWT639118A, PWDII75DF - ARDPWT639119A, PWDII50SF -. Recalled by Getinge Usa Sales Inc. Units affected: 236793 units in total.
Why was this product recalled? ▼
A potential for a light system to fall in the operating room.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2024. Severity: Moderate. Recall number: Z-0757-2024.

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