Z-1154-2009

Alm Prismatic Surgical Light 5004 SF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide...

Name: Z-1154-2009 Alm Prismatic Surgical Light 5004 SF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide...
Creator: MAQUET Inc.
Published: 2009-02-23
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2009-02-23 / Terminated / root cause: design

FDA source

MAQUET Inc. began a recall of Alm Prismatic Surgical Light 5004 SF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the... on 2009-02-23. The reason FDA records is "The screws holding the Prismatic triple surgical lights may break due to dynamic multidirectional bending stress. The firm has received one complaint report". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1154-2009
Status: Terminated
Initiated: 2009-02-23
Posted: 2009-04-12
Terminated: 2009-09-29
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: Alm Prismatic Surgical Light 5004 SF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.
Product code: FTD Lamp, Surgical
Reason for recall: The screws holding the Prismatic triple surgical lights may break due to dynamic multidirectional bending stress. The firm has received one complaint report.
Root cause tag: design
FDA root cause: Device Design
Action: An "Urgent Device Correction" letter dated February 23, 2009 was mailed by FedEx Tracking to all affected consignees. The letter described the issue, potential hazard and recommended precaution. Customers were instructed to complete the enclosed "Customer Response Fax Form" and return it via fax (1-732-667-1903) to Maquet, Inc. Maquet, Inc. will schedule repair service of the affected units once the "Customer Response Fax Form" is received. Direct questions to your local Maquet, Inc. Representative.
Quantity in commerce: 54 of all units, both article numbers
Distribution: Nationwide Distribution.
Product codes and lots: Article Number: 567030999; Serial Numbers: 6041, 6042, 6043, 6044, 6045, 6046, 6047, 6048, 6049, 6050, 6051, 6052, 6053, 6054, 6057, 6058, 6059, 6060, 6061 and 6062.

Product code FTD

K882613Class IIAlm Surgical LampsAlm Surgical Equipment, Inc. / cleared 1988-07-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)