Device recall: ProxiDiagnost N90; Model Number: 706110;
Philips Medical Systems DMC GmbH (Hamburg) initiated this device recall on 1 Oct 2025; FDA lists 6 product records under event 97748, classified Class II.
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. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. 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
"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."
Distribution
"Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0461-2026 | ProxiDiagnost N90; Model Number: 706110; | 41 units | Class II | Ongoing | 19 Nov 2025 |
| Z-0462-2026 | CombiDiagnost R90; Model Number: 709031; | 17 units | Class II | Ongoing | 19 Nov 2025 |
| Z-0463-2026 | Precision CRF; Model Number: 706400; | 42 units | Class II | Ongoing | 19 Nov 2025 |
| Z-0464-2026 | DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032; | 12 units | Class II | Ongoing | 19 Nov 2025 |
| Z-0465-2026 | DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035; | 223 units | Class II | Ongoing | 19 Nov 2025 |
| Z-0466-2026 | Radiography 7300 C; Model Number: 712037; | 284 units | Class II | Ongoing | 19 Nov 2025 |
Context
Other enforcement events for Philips Medical Systems DMC GmbH
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 May 2021 | ProxiDiagnost N90. radiography and fluoroscopy system | Device | Class II | 5 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
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: "Worldwide Distribution: US (Nationwide) Distribution and OUS (International) countries of: Australia, Austria, Bahrain, Belgium, Bosnia-Herz., Canada, Chile, Croatia, Denmark, Estonia, Finland,…"
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.