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Terminated

Neoprobe GDS Control Unit, Model Number NPCU3

FDA Recall Z-0070-2021 · Posted None

Recalling FirmDevicor Medical Products Inc
Recall StatusTerminated
Product CodeIZD
Date Initiated2020-09-07
Date Terminated2023-05-09
Product Quantity49

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.

Firm 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].

Root Cause

Process design

Distribution Pattern

The products were distributed only to China.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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