Recall Z-0070-2021 ยท IZD Probe, Uptake, Nuclear
Devicor Medical Products Inc
Neoprobe GDS Control Unit, Model Number NPCU3
| Date | Sep 7, 2020 |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 49 |
| Distribution | The products were distributed only to China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.