| | Class 2 Device Recall Brilliance CT Big Bore |  |
| Date Initiated by Firm | April 01, 2025 |
|---|
| Date Posted | April 23, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1660-2025 |
|---|
| Recall Event ID |
96667 |
| 510(K)Number | K171850 |
|---|
| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
| Product | Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System. |
|---|
| Code Information |
Model No. 728242, 728243, 728244; UDI: (01)00884838098725(21)7014, (01)00884838098725(21)7032, (01)00884838059450(21)7056, (01)00884838098725(21)7060, (01)00884838098725(21)7062, (01)00884838098725(21)7064, (01)00884838098725(21)7072, (01)00884838098725(21)7087, (01)00884838059450(21)7096, (01)00884838059450(21)7123, (01)00884838059450(21)7124, (01)00884838098725(21)7128, (01)00884838098725(21)7135, (01)00884838098725(21)7154, (01)00884838098725(21)7163, (01)00884838098725(21)7179, (01)00884838098725(21)7191, (01)00884838098725(21)7220, (01)00884838098725(21)7221, (01)00884838098725(21)7229, (01)00884838059450(21)7240, (01)00884838098725(21)7245, (01)00884838098725(21)7246, (01)00884838098725(21)7247, (01)00884838098725(21)7254, (01)00884838098725(21)7256, (01)00884838098725(21)7282, (01)00884838098725(21)7283, (01)00884838098725(21)7292, (01)00884838098725(21)7297, (01)00884838098725(21)7304, (01)00884838098725(21)7306, (01)00884838098725(21)7309, (01)00884838098725(21)7311, 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Recalling Firm/
Manufacturer |
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
|
| For Additional Information Contact | Philips Customer Care Solutions Center
1-800-722-9377 |
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Manufacturer Reason
for Recall | Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient. |
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FDA Determined
Cause 2 | Software design |
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| 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 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. |
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| Quantity in Commerce | 630 units |
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| 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, Mauritius, Mexico, Monaco, Morocco, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Puerto Rico, R¿union, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, T¿rkiye, Turkmenistan, United Kingdom, UAE & Yemen. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = JAK
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