Z-1588-2023 Class II Ongoing
FDA device recall Z-1588-2023 was initiated by Philips North America on March 3, 2023 and is designated Class II. Reason for recall: Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Adm… The recall status is ongoing. Affected quantity: 25 systems in total.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- March 3, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 25 systems in total
Product Description
CombiDiagnost R90 R.1.0
Reason for Recall
Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
Distribution Pattern
US Nationwide
Code Information
REF number 709030 Serial number 10001076