Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
FDA device recall Z-1660-2025 · posted 2025-04-23 · Open, Classified
Recall details
- Recalling firm
- Philips North America Llc
- Reason for recall
- Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
- Action taken
- An "URGENT Medical Device Correction" Notice dated 4/1/25 was mailed to consignees. The notice instructs consignees on how to identify if their unit is affected by this recall. Consignees are instructed to continue use of affected devices by following the recommended actions outlined in the notice and Appendix A. Consignees are asked to return the completed URGENT Medical Device Correction Response Form within 30 days of notification of this recall event via email: Philips.Recall@philips.com. The recall notification is to be circulated among users and retained near affected devices until the update is installed. Philips will be contacting consignees to schedule a Field Service Engineer to visit affected sites and install the update (FCO72800825). Consignees with any questions are to call the Customer Care Solutions Center at 1-800-722-9377.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- 630 units
- Distribution
- Worldwide distribution: US (Nationwide); and OUS (Foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Czech Republic, Estonia, France, Ger
- Date initiated
- 2025-04-01
- Date posted
- 2025-04-23
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Philips CT Big Bore (K171850) | Philips Medical Systems (Cleveland), Inc. | 2017-11-09 |