Z-1130-2019 Class II Terminated
FDA device recall Z-1130-2019 was initiated by Philips North America, LLC on March 12, 2019 and is designated Class II. Reason for recall: During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector. The recall status is terminated (terminated October 7, 2020). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2019
- Initiation Date
- March 12, 2019
- Termination Date
- October 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Azurion FlexArm, 722079
Reason for Recall
During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.
Distribution Pattern
Distributed to one account in Florida, and one international account in Germany.
Code Information
Serial numbers 637, 638