Devicor Medical recalls Neoprobe GDS Control Units (Model NPCU3) with China-specific software version v6.01 that may not meet China's regulatory standards. Affected units were sold in China since 2011.
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.
Devicor Medical is recalling Neoprobe GDS Control Units (Model NPCU3) that were sold in China since 2011 with software version v6.01. This version does not meet China's regulatory requirements for the device, potentially causing compliance issues in the Chinese market.
The device was distributed in China with software version v6.01, while China requires version v5.01 for regulatory compliance. This discrepancy means the device may not meet Chinese regulatory standards, potentially leading to compliance issues or operational restrictions in China.
Users of Neoprobe GDS Control Units (Model NPCU3) sold in China since 2011 are affected. Medical professionals using these devices in China may be at risk due to regulatory non-compliance.
Check for the model number NPCU3 on the device. Units sold in China since 2011 with software version v6.01 are affected. Serial numbers listed in the recall include 122066557 through 151267974.
Compare your device's serial number to the list provided in the recall to determine if it is affected.
The recall is due to software version v6.01 not meeting China's regulatory requirements, as China requires version v5.01 for compliance.
The recall does not specify any action required for users outside of China. Affected units in China should check the serial number list provided.
The recall record does not mention any remedy or fix for the software version discrepancy.
We’ve drafted a message you can send Devicor Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0070-2021 — Devicor Medical Devicor Medical Hello, I own a Devicor Medical that is covered by recall Z-0070-2021 from Devicor Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
