Recall Z-1660-2025 ยท JAK System, X-Ray, Tomography, Computed
Philips North America Llc
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
| Date | Apr 23, 2025 (initiated Apr 1, 2025) |
| Status | Open, Classified |
| Reason | Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient. |
| Root cause | Software design |
| Action | 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 u |
| Quantity | 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, Germany, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Lebanon, Libya, Luxembourg, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171850 | Philips CT Big Bore Philips Medical Systems (Cleveland), Inc., Nov 9, 2017 |