Device recall: ProxiDiagnost N90. radiography and fluoroscopy system
FDA enforcement event 90490 is a device recall by Philips Medical Systems DMC GmbH of Hamburg, initiated 19 May 2021 and classified Class II, with 5 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Ongoing. Initiation: fda mandated. Philips Medical Systems DMC GmbH has 2 enforcement events on this register, with a median of 6 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips Medical Systems DMC GmbH, Hamburg, Germany.
Reason for recall
"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…"
Distribution
"US Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1325-2022 | ProxiDiagnost N90. radiography and fluoroscopy system | 140 systems in total, (Updated 1/30/2023). | Class II | Ongoing | 20 Jul 2022 |
| Z-1326-2022 | DigitalDiagnost 4 High Performance. radiography and fluoroscopy system | 140 systems in total, (Updated 1/30/2023). | Class II | Ongoing | 20 Jul 2022 |
| Z-1327-2022 | DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system | 140 systems in total, (Updated 1/30/2023). | Class II | Ongoing | 20 Jul 2022 |
| Z-1328-2022 | DigitalDiagnost C90 High Performance. radiography and fluoroscopy system | 140 systems in total, (Updated 1/30/2023). | Class II | Ongoing | 20 Jul 2022 |
| Z-1329-2022 | DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system | 140 systems in total, (Updated 1/30/2023). | Class II | Ongoing | 20 Jul 2022 |
Context
Other enforcement events for Philips Medical Systems DMC GmbH
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Oct 2025 | ProxiDiagnost N90; Model Number: 706110; | Device | Class II | 6 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.