Neoprobe GDS Control Unit, Model Number NPCU3
Reported: October 14, 2020 Initiated: September 7, 2020 #Z-0070-2021
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.
Details
- Recalling Firm
- Devicor Medical Products Inc
- Units Affected
- 49
- Distribution
- The products were distributed only to China.
- Location
- Cincinnati, OH
Frequently Asked Questions
What product was recalled? ▼
Neoprobe GDS Control Unit, Model Number NPCU3. Recalled by Devicor Medical Products Inc. Units affected: 49.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 14, 2020. Severity: Low. Recall number: Z-0070-2021.
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