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.
This recall has been terminated (originally issued May 21, 2010).
- Company
- Stryker Communications Corp
- Recall Initiated
- April 15, 2010
- Posted
- May 21, 2010
- Terminated
- January 24, 2011
- Recall Number
- Z-1645-2010
- Firm Location
- Flower Mound, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Installation records are incomplete.
Distribution
Nationwide Distribution
Lot / Code Info
Product installed Between January 1, 2008 and August 31, 2009.
Root Cause
Employee error
Action Taken
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 StrykerCommunicationsRA@stryker.com.