Devicor Neoprobe GDS Control Unit Recalled for Software Version Mismatch
Devicor Medical Products Inc is recalling 49 Neoprobe GDS Control Units distributed to China because the installed software version does not match the approved version.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation and software version mismatch without reported injuries.
Plain-English summary
Devicor Medical Products Inc is recalling 49 units of the Neoprobe GDS Control Unit, Model Number NPCU3. The recall was initiated after a documentation review revealed that the software version installed on devices distributed in China since 2011 is v6.01, whereas the version approved for use in China is v5.01.
The affected products were distributed only to China. The recall involves specific serial numbers listed in the agency's official documentation. No illnesses or injuries have been reported in connection with this recall.
Consumers and healthcare providers in China who possess these specific units should contact Devicor Medical Products Inc for further instructions regarding the software discrepancy.
The recalled product
- Product
- Neoprobe GDS Control Unit, Model Number NPCU3
- Manufacturer
- Devicor Medical Products Inc
- Affected units
- 49
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00841911100317
Distribution
Distribution scope not specified by the agency.
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