Z-1587-2023 Class II Ongoing
FDA device recall Z-1587-2023 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
ProxiDiagnost N90 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 706100 Serial number 10001015, 10001019, 10001020, 10001021, 10001022, 10001023, 10001026, 10001027, 10001028, 10001030, 10001033, 10001036, 10001037, 10001038, 10001039, 10001040, 10001042, 10001051, 20000067.