Z-1730-2014Class II

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

Name: Z-1730-2014 Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient
Creator: Maquet Medical Systems USA
Published: 2014-04-16
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2014-04-16 / Terminated

FDA source

Maquet Medical Systems USA began a recall of Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient on 2014-04-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1730-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-16
Posted: 2014-06-06
Terminated: 2016-04-06
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: 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.
FDA 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 in commerce: United States 1169 units
Distribution: US Nationwide Distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1730-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1730-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-06

Product code FSY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)