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.
FDA Recall Z-1154-2009 · Posted 2009-04-12
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Recalling FirmMAQUET Inc.
Recall StatusTerminated
Product CodeFTD
Date Initiated2009-02-23
Date Terminated2009-09-29
Product Quantity54 of all units, both article numbers
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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