Philips DXR System (Philips) – collimator fall risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Brand
Philips North America Llc
Lot Codes / Batch Numbers
REF 712203, UDI: (01)00884838095205(21), Serial No. 220025, 210023, 220171, 230103, 230152.
Products Sold
REF 712203; UDI: (01)00884838095205(21); Serial No. 220025, 210023, 220171, 230103, 230152.
Philips North America Llc is recalling Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System. due to Potential for collimator to fall as a result of incorrect installation.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for collimator to fall as a result of incorrect installation.
Recommended Action
Per FDA guidance
Consignees received an URGENT MEDICAL DEVICE CORRECTION NOTICE dated 3/7/25. The notice instructs customers of safety precautions to take during scan preparation to ensure devices are fit for use. If consignees notice that the laser from the collimator or crosshairs of the collimator's light field is not able to align with the silkscreen on the front cover of the detector, consignees are to immediately stop use and call their Philips representative. The provided notice is to be posted near affected systems and circulated to all device users. Philips will reach out to consignees to schedule an inspection of devices by field service engineers. Engineers may also replace the collimator, if necessary. Consignees with questions are to call Philips Customer Care Solutions Center at 1-800-722-9377 from Monday through Friday (8:00 AM to 8:00 PM EST).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026