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Terminated

Ceiling Suspensions (Surgical Light and Flat Panel Suspensions); Catalog Numbers: 0682000863, 06820001009, 0682001010, 0682001076, 0682000864, 0682000857, 0682000858, 0682001077, 0682000865, 0682001011, 0682001078, 0682000866, 0682001012, 0682001080, 0682000867, 0682000959, 0682001079, 0682000850, 0682000851, 0682000852, 0682001269, 0682001567, 0682001569, 0682001570, 06820012691, 06820015671, 06820015691, & 0680015701. The ceiling suspensions are available in different configurations; they can hold monitors (flat panel suspensions), cameras (navigation suspensions arms) or surgical lights. The flat panel could have fixed or adjustable monitor yokes and may be single or dual arm configuration. Each ceiling suspension could hold a maximum of two surgical lights and either one camera or one monitor. There may be multiple ceiling/boom suspensions in an operating room. Intended for use as ceiling-mounted devices for supporting or positioning surgical lights, cameras, and/or monitors.

FDA Recall Z-1645-2010 · Posted 2010-05-21

Recalling FirmStryker Communications Corp
Recall StatusTerminated
Product CodeBRY
Date Initiated2010-04-15
Date Terminated2011-01-24

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.

K033132STRYKER SWITCHPOINT INFINITYStryker Communications Corp. · 2004-09-02K031068STRYKER VISUM SURGICAL LIGHTING SYSTEMStryker Endoscopy · 2003-08-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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