FDAClass IIJune 18, 2014

Maquet PowerLED 700. Product Usage recall

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

Why was Maquet PowerLED 700. Product Usage 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part number (begins with ALM) and associated serial numbers: 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, 77, 78, 80, 81 ALM568303999 8, 9, 32, 52, 53, 58, 60, 61, 62, 65, 66, 69, 70, 71, 73, 74, 75, 77, 78, 79, 80, 81, 82, 85, 86, 87, 89, 91, 92, 94, 95, 96, 97, 99, 100, 105, 106, 108, 111, 118, 120, 121, 122, 159 ALM568320901 12012, 40015, 40017, 40018, 40019, 40020, 40021, 50010, 50011, 50012, 50013, 50014, 50015, 50016, 50017, 50018, 50019, 50020, 50021, 50022, 50023, 50024, 50025, 50026, 50027, 50028, 50030, 50031, 50032, 50033, 50034, 50035, 50037, 50038, 50039, 50040, 50041, 50042, 50043, 50047, 50048, 50050, 50051, 50052, 50053, 50054, 50055, 50056, 50058, 50059, 50060, 50061, 50064, 50066, 50067, 50068, 50069, 50070, 50071, 50072, 70033, 70034, 70035 ALM568320905 40003, 40004, 40005, 40006, 40007, 40008, 40009, 40010, 40011, 40012, 40013, 40014, 40015, 40016, 50003, 50004, 50005, 50006, 50008, 50009, 50010, 50011, 50012, 50013, 50014, 50015, 50016, 50017, 50018, 50019, 50020, 50021, 60003, 60004, 70001, 70002, 70003, 70004, 70005, 70006, 70007, 70009, 70010, 70011, 70012, 70013, 70014, 70015, 70016, 70017, 70018, 70019, 70020, 70021, 70022, 70024, 70025, 70027, 70028, 70029, 70030, 70031, 70032, 70033, 70034, 70035, 70036, 70037, 70038, 70039, 70040, 70041, 70042, 70043, 70044, 70045, 70046, 70047, 70048, 70049, 70050, 70051, 70052, 70053, 70054, 70055, 70056, 70057, 70058, 70059, 70060, 70061, 70063, 70064, 70066, 70068, 70069 ALM568370900 20017, 20018, 20019, 20020, 20021, 20022, 20023, 20024, 20025, 20026, 20027, 20028, 20029, 20030, 20039, 20040, 20041, 20042, 20043, 20044, 20045, 20046, 20047, 20048, 20049, 20050, 20051, 20052, 20053, 20054, 30038, 30039, 30053, 30054, 40006, 40010, 40012, 40013, 40014, 40015, 40016, 40018, 40019, 40020, 40027, 40028, 40029, 40030, 40031, 40032, 40033, 40034, 50000, 50001, 50004, 50006, 60007, 60008, 60009, 60010, 60012, 60031, 60041, 60042, 60043, 60044, 60046, 60047, 60048 ALM568370901 20024, 20025, 20026, 20027, 20028, 20029, 20030, 20031, 20032, 20033, 20034, 20038, 20039, 20040, 20041, 20042, 20045, 20053, 20054, 20055, 20056, 20057, 20058, 20059, 20060, 20061, 20062, 20064, 20065, 20066, 20067, 20068, 20069, 20070, 32042, 40028, 40033, 40034, 40035, 40036, 40037, 40038, 40045, 50002, 50006, 50008, 50009, 50024, 50035, 50036, 50037, 50039, 50040, 50041, 50042, 50043, 50044, 50045, 50046, 50047, 50048, 60030 ALM568370902 20011, 20015, 20016, 20017, 20018, 20019, 20020, 20021, 20022, 20023, 20024, 20025, 20026, 20027, 20028, 20029, 20030, 20031, 20032, 20033, 20034, 20035, 20036, 20037, 20038, 20039, 20040, 20041, 20042, 20048, 20049, 20050, 20051, 20057, 20058, 20059, 20060, 20061, 20062, 20063, 20064, 20067, 20068, 20069, 20070, 20071, 20072, 20073, 20074, 20075, 20076, 20077, 20078, 20079, 20080, 20083, 20086, 20087, 20089, 20090, 20091, 20094, 20095, 20096, 20098, 20104, 20105, 20106, 20107, 20108, 20109, 20110, 20111, 20112, 20113, 20114, 20115, 20116, 20117, 20118, 20119, 20120, 20121, 20122, 20123, 20124, 20125, 20127, 20132, 20133, 20135, 20136, 20137, 20139, 20140, 20141, 20144, 20151, 20152, 30000, 30051, 30053, 30054, 30062, 30063, 30065, 30066, 30067, 30068, 30078, 30081, 30090, 30091, 30092, 30099, 30107, 30127, 30128, 30130, 30131, 30134, 32164, 40000, 40006, 40007, 40009, 40011, 40012, 40013, 40014, 40015, 40017, 40018, 40019, 40020, 40021, 40023, 40039, 40040, 40041, 40042, 40043, 40044, 40045, 40046, 40047, 40048, 40050, 40051, 40052, 40053, 40054, 40055, 40056, 40057, 40058, 40060, 40064, 40065, 40067, 40078, 40081, 40082, 40083, 40084, 60030, 60031, 60036 ALM568370903 20022, 20023, 20024, 20025, 20026, 20027, 20028, 20029, 20030, 20032, 20033, 20034, 20035, 20036, 20037, 20038, 20039, 20041, 20043, 20044, 20045, 20046, 20047, 20048, 20049, 20050, 20051, 20052, 20053, 20055, 20056, 20057, 20058, 20059, 20066, 20067, 20072, 20073, 20074, 20075, 20076, 20077, 20079, 20080, 20081, 20082, 20084, 20087, 20088, 20089, 20090, 20091, 20092, 20093, 20097, 20098, 20099, 30072, 40025, 50000, 50001, 50002, 50003, 50004, 50006, 50028, 50051, 50052, 50054, 50055, 50057, 50058, 50059, 50060, 60024, 60025, 60026, 60028 ALM568370904 20011, 20013, 20014, 20015, 20016, 20017, 20018, 20019, 20020, 20023, 20024, 20025, 20026, 20027, 20032, 20033, 20034, 20035, 20036, 20037, 20038, 30000, 30001, 30002, 30003, 30004, 30012, 30013, 30014, 30015, 30018, 30019, 30020, 30025, 30026, 30027, 30028, 30029, 30030, 30031, 30032, 30033, 30034, 30035, 30036, 30037, 30038, 30039, 30040, 30041, 30042, 30043, 40011, 40012, 40013, 40014, 40015, 40016, 40017, 40022, 40023, 40024, 40031, 40032, 40033, 40034, 40035, 40036, 50004, 50010, 50011, 50012, 50013, 50014, 50015, 50016, 50017, 50019 ALM568370905 20010, 20016, 20017, 20018, 20019, 20022, 20023, 30027, 40012, 40022, 40023, 40024, 40025, 40027, 40028, 40029, 40031, 40032, 40033, 40037, 40040, 40041, 40047, 40049, 40050, 50005, 50006, 50012, 50015, 50018, 50021, 60007, 60023, 60027, 60030, 60032, 60033

Product
Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.
Recalling firm
Maquet Medical Systems USA
Quantity
United States 1169 units
Distribution
US Nationwide Distribution.
Recall date
June 18, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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