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

Recall number

Z-1730-2014

Recalling firm

Maquet Medical Systems USA

Product

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

Status

Terminated

Initiated

2014-04-16

Posted

2014-06-06

Terminated

2016-04-06

Reason

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.

Root cause

Other

Action

Maquet issued "Urgent-Medical Device Field Correction" notices, dated April 16, 2014 to affected customers via Federal Express. The notice identified the product, related issue and the action needed to be taken by the customer. The corrective action will include inspection of the fixation tabs of the Ambient Light Module adn replacement of the Ambient Light Module if tabs are found to be defective. The correction will be performed by an authorized MAQUET Service Technician. MAQUET Service Team representatives will schedule on-site service with customers. If customers have any questions or require additional information, the notice instructs them to contact their local MAQUET representative, or MAQUET Customer Service at 1-888-627-8383 (option 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.

Quantity

United States 1169 units

Distribution

US Nationwide Distribution.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

FSY

Firm FEI

3008355164

Firm city

Wayne

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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