Recall Z-0979-2024 ยท KQM Camera, Surgical And Accessories
Barco N.V.
Barco MDSC-8527 NXF, Part Number K9352421
| Date | Feb 2, 2024 (initiated Dec 20, 2023) |
| Status | Open, Classified |
| Reason | Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx NXF products. The functionality of the built-in MNA decoder is blocked. |
| Root cause | Under Investigation by firm |
| Action | Barco sent an email to their sole consignee on 12/14/2023 regarding the issue with the device and followed with a Customer Notice issued on 12/20/2023, also by email. The notice explained the issue, potential risk, and requested the following actions: A) Assess & locate the affected units and block them for further distribution. Please identify affected devices and find out where they are. These units should not be further processed within the distribution chain. B) Return the units to Barco Please return the products to Barco using the RMA form received by Barco. This form will be communic |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the state of New Jersey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.