Reported Dec 21, 2016 · Terminated
Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical…
Steris Corporation
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: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834
Is this the product you have?
- Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required
- Lot codes and dates
64 of 64 codes
041901616004214161230420816119041521609504090160390409016038040471612704348150150429915001042991500204180150660418015065041681500204160150020416015001041351501204096150110407615001040761500204050151020429614003040151501504317140010430914002043091400104276140220428014006042391401404217140070416814001041501400204143140820413914001041271404304114140010411414003041141400204111140010401614001040481412804050140140403814116040221407604013141310401514013040061402704344130190433813017042911316404301131490427313064041701308304148130010412113002041211300104100130010405213038040441301804044130170404413016
- Amount recalled
- 63
Where it was sold
Why it was recalled
The Drager Pendula spring arm device has a set of screws located on the spring arm that were not properly secured with Loctite and may become loose.
This product could cause temporary or reversible health problems — stop using it.
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