Devicor Medical Products Inc: Neoprobe GDS Control Unit, Model Number NPCU3

Is my product affected?

Neoprobe GDS Control Unit, Model Number NPCU3

• UPC 00841911100317

Check against the official notice below — it lists the full affected range.

What happened

Devicor Medical Products Inc. is recalling 49 Neoprobe GDS Control Units (Model NPCU3) that were distributed to China since 2011. The recall was initiated after a documentation review revealed that these devices are running software version v6.01, while China's approved software version for this device is v5.01.

The recall affects devices with UDI 00841911100317 and 47 specific serial numbers listed in the recall documentation. The recall record does not specify a remedy or required consumer action.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: The products were distributed only to China. Quantity: 49 Lot/code info: UDI: 00841911100317; Serial Numbers: 122066557 122066558 122066559 122066560 122066561 122666652 123066667 123066668 123066669 123366695 123366696 123366697 123366698 123366699 123366700 123366701 123366702 123266693 123266694 134467282 143367591 144867780 145067796 150367828 150367829 150367840 150467866 150467867 150367830 150367831 150367832 150967913 150967914 151067915 151067916 151067917 151267970 151267971 151267972 151267973 151267974 185269399 185269403 190269421 190469433 190469430 190469428 150467871 150467869

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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