Recall Z-0465-2026— Philips Medical Systems DMC GmbH
Class II · Ongoing
Class II FDA medical device recall by Philips Medical Systems DMC GmbH, initiated 2025-10-01. It names one FDA 510(k) clearance: K202564. Product: DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;. 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..
- Recalling firm
- Philips Medical Systems DMC GmbH
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-01
- Firm location
- Hamburg, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Number: (1) 712034, (2) 712035;
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.