Stryker VISUM Halogen Surgical Lights (Ceiling Mounted Surgical Lights), Catalog Number: 0682000106; 0682000107. Intended to illuminate the operative site during surgical procedures with high intensity light.
FDA Recall Z-1642-2010 · Posted 2010-05-21
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Recalling FirmStryker Communications Corp
Recall StatusTerminated
Product CodeFSY
Date Initiated2010-04-15
Date Terminated2011-01-24
Product Quantity608 (lights and booms)
Reason for Recall
Installation records are incomplete.
Firm Action
An Urgent: Medical Device Product Correction customer notification letter, dated 4/15/2010, has been sent out to all affected accounts via regular mail in the form of a certified, return request receipt letter. Accounts will receive a follow-up phone call from a Stryker Representative to schedule a re-inspection of equipment to see if it mets established critical specifications or not. The firm recommends that customers continue using all Stryker Communications products listed in the notice. Questions can be directed to Katie Blackwell at 972-410-7660 or via email at [email protected].
Root Cause
Employee error
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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