Z-0070-2021Class III

Neoprobe GDS Control Unit, Model Number NPCU3

Name: Z-0070-2021 Neoprobe GDS Control Unit, Model Number NPCU3
Creator: Devicor Medical Products Inc
Published: 2020-09-07
License: https://open.fda.gov/license/

Devicor Medical Products Inc / initiated 2020-09-07 / Terminated / root cause: manufacturing process

FDA source

Devicor Medical Products Inc began a recall of Neoprobe GDS Control Unit, Model Number NPCU3 on 2020-09-07. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0070-2021
Classification: Class III
Status: Terminated
Initiated: 2020-09-07
Posted: 2020-10-08
Terminated: 2023-05-09
Recalling firm: Devicor Medical Products Inc
Product: Neoprobe GDS Control Unit, Model Number NPCU3
Product code: IZD Probe, Uptake, Nuclear
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: URGENT FIELD CORRECTION notification letters were sent to customers. Action to be taken by the user: As a result of this notification, please conduct the following: " Please Examine your inventory, identify and reference attached product list to determine if you have an affected device. " If you have any Devices referenced, immediately contact Minghui Qian at +86 21 8031 6329 " If in use on a patient, continue to use the device if an alternative device is not available. " Please complete and return the enclosed Response Form of Acknowledgement. " If you have any additional questions, comments or concerns please contact our Customer Support at +86 21 8031 6329. You may also email [email protected].
Quantity in commerce: 49
Distribution: The products were distributed only to China.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0070-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0070-2021	Class III	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-08

Product code IZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)