FDA Device recall Z-0464-2026
DigitalDiagnost 4 (1) High Performance, (2) Flex/Value
- FDA Device
- Class II
- ongoing
- Published 2025-11-19
On 2025-11-19 the FDA classified a Class II recall of DigitalDiagnost 4 (1) High Performance, (2) Flex/Value by Philips Medical Systems Dmc, citing philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0464-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-01 |
| Published | 2025-11-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Philips Medical Systems Dmc |
| Distribution | US |
Product
DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;
Reason
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
Identifiers
| code_info | 1. Model Number: 712031; UDI-DI: 00884838065321; Serial Numbers: 10001181, 10001182, 10001185, 10001186, 10001188, 1000…1. Model Number: 712031; UDI-DI: 00884838065321; Serial Numbers: 10001181, 10001182, 10001185, 10001186, 10001188, 10001189, SN16000022, SN20000013; 2. Model Number: 712032; UDI-DI: 00884838074514; Serial Numbers: 10001179, 19000341, 19000342, 19000343; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0464-2026%22
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