Recall Z-1553-2025— Philips North America Llc
Class II · Ongoing
Class II FDA medical device recall by Philips North America Llc, initiated 2025-03-10. It names 2 FDA 510(k) clearances: K201640, K141381. Product: Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.. Reason: Potential for collimator to fall as a result of incorrect installation..
- Recalling firm
- Philips North America Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-10
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
2 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
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Reason for recall
Potential for collimator to fall as a result of incorrect installation.
Data sourced from openFDA. This site is unofficial and independent of the FDA.