Reported Oct 14, 2020 · Terminated
Neoprobe GDS Control Unit, Model Number NPCU3
Devicor Medical Products Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Devicor Medical Products Inc · 300 E Business Way Fl 5 · Cincinnati, OH · 45241-2384
Is this the product you have?
- Neoprobe GDS Control Unit, Model Number NPCU3
- Lot codes and dates
- UDI00841911100317
- Serial Numbers
122066557122066558122066559122066560122066561122666652123066667123066668123066669123366695123366696123366697123366698123366699123366700123366701123366702123266693123266694134467282143367591144867780145067796150367828150367829150367840150467866150467867150367830150367831150367832150967913150967914151067915151067916151067917151267970151267971151267972151267973151267974185269399185269403190269421190469433190469430190469428150467871150467869
- Amount recalled
- 49
Why it was recalled
It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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