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Unrated Medical device recall · FDA · Published September 7, 2020

Neoprobe GDS Control Unit v6.01 Software Recalled for China Compliance

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0070-2021Medical deviceDevicor Medical ›
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Recalling firmDevicor Medical Products Inc300 E Business Way Fl 5 · Cincinnati, OH 45241-2384
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/64373-neoprobe-gds-control-unit-v6-01-software-recalled-for-china.

Source Summary by GovInfoNow · govinfonow.com/recall/64373-neoprobe-gds-control-unit-v6-01-software-recalled-for-china · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0070-2021

Cite this page

“Neoprobe GDS Control Unit v6.01 Software Recalled for China Compliance.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64373-neoprobe-gds-control-unit-v6-01-software-recalled-for-china. Based on FDA recall #Z-0070-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0070-2021%22&limit=1).

The FDA announced on 2020-09-07 that Devicor Medical Products Inc is recalling the Neoprobe GDS Control Unit, Model Number NPCU3. The agency cited a software version discrepancy for devices distributed in China.

How to tell if you have it

  • Brand: Devicor Medical
  • Product: Neoprobe GDS Control Unit
  • Model Number: NPCU3
  • 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
  • Distribution: China

The hazard

GovInfoNow's records show the recall stems from a documentation review finding that devices distributed in China since 2011 contain software version v6.01, whereas version v5.01 was approved for use in that region.

Context

GovInfoNow's records show Devicor Medical Products Inc has issued two other recalls since 2022-03-30, including a HydroMARK Breast Biopsy Marker recall on 2026-04-24 for incorrect labeling and another on 2022-03-30 for label mismatch risks. Other recent recalls of similar products include Siemens CT Software Applications Recalled: Unapproved Medical Software (2025-12-19), Medline GYN Laparoscopy Kits recalled due to regulatory clearance rescission (2026-02-25), and Medline D&C Pack Kits with rescinded regulatory clearances (2026-02-25).

How to tell if you have this one

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.

  • Brand
    Devicor Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Serial Number

    Compare your device's serial number to the list provided in the recall to determine if it is affected.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

1. Firm started the recall: Sep 7, 202012. FDA classified it Class III: Oct 8, 202023. Published in FDA’s Enforcement Report: Oct 14, 202034. FDA terminated the recall: May 9, 2023420202023
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-0070-2021 (September 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0070-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA