Reported Apr 5, 2017 · Terminated
The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures…
Stryker Communications
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Communications · 1410 Lakeside Pkwy Ste 100 · Flower Mound, TX · 75028-4026
Is this the product you have?
- The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP), 0682001298 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P), 0682001299 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/5P), 0682001300 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/5P/5P), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS
- FP/9P/5P) Product UsageThe Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light
- Lot codes and dates
- "Serial
- Numbers
100000000098399100000000099187100000000099193100000000093937100000000094391100000000093936100000000087555100000000091032100000000093938100000000093928100000000093939100000000098397100000000092672100000000093927100000000106675100000000106685100000000109560100000000109569100000000109570100000000086360100000000089194100000000091766100000000091778100000000098401100000000099325100000000103228100000000090520100000000102434100000000102439100000000103111100000000088303100000000089467100000000094993100000000095927100000000101580100000000092699100000000101590100000000101591100000000103686100000000109291100000000097048100000000112633100000000087549100000000094982100000000091762100000000112607100000000112609100000000091531100000000106681100000000106682100000000106684100000000106159100000000091728100000000103271100000000090522100000000099356100000000089970100000000090530
- Amount recalled
- 292 devices (in US)
Where it was sold
- Nationwide
- PR
Why it was recalled
The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall.
This product could cause temporary or reversible health problems — stop using it.
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