Recall Z-0070-2021— Devicor Medical Products Inc
Class III · Terminated
Class III FDA medical device recall by Devicor Medical Products Inc, initiated 2020-09-07, terminated 2023-05-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Neoprobe GDS Control Unit, Model Number NPCU3. Reason: 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..
- Recalling firm
- Devicor Medical Products Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-09-07
- Terminated
- 2023-05-09
- Firm location
- Cincinnati, OH, United States
Product description
Neoprobe GDS Control Unit, Model Number NPCU3
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.