FDA Device recall Z-1588-2023
CombiDiagnost R90 R.1.0
- FDA Device
- Class II
- ongoing
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class II recall of CombiDiagnost R90 R.1.0 by Philips North America, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1588-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-03 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
CombiDiagnost R90 R.1.0
Reason
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).
Identifiers
| code_info | REF number 709030 Serial number 10001076 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1588-2023%22
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