FDA Device recall Z-1327-2022
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
- FDA Device
- Class II
- ongoing
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system by Philips Medical Systems Dmc, citing following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the fi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1327-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-19 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Medical Systems Dmc |
| Distribution | US |
Product
DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system
Reason
Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.
Identifiers
| code_info | Model 712032 Serial Numbers - 10001088 10001097 10001104 10001112 19000317 10001095 10001102 10001105 |
|---|
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-1327-2022%22
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