Philips Spectral CT on Rails, Model 728334 - Class II Recall (Z-1825-2026)

Class 2 Device Recall Philips Spectral CT on Rails

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| | Class 2 Device Recall Philips Spectral CT on Rails | |

222 Jacobs St
Cambridge MA 02141-2289 |
| For Additional Information Contact | Philips Customer Care Solutions Center
800-722-9377 |
| Manufacturer Reason
for Recall | Philips has identified three software issues:
1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go.
2. Potential where the message of Previous Surview Exists Select Previous Surview? or should display but does not appear.
3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out. |
| FDA Determined
Cause | Under Investigation by firm |
| Action | Philips Medical notified consignees on about 03/07/2026 via letter. Consignees were instructed to identify any affected systems in inventory and specifically for each issue:
1. Issue #1: Ensure to follow the instructions mentioned in the IFU Section 4 Preparing for an Examination and Sub section Gantry Operation.
2. Issue #2: Avoid the Select Previous Surview Unavailable issue, manually remove the
patient's middle name while importing the patient detail from HIS/RIS.
3. Issue #3: if Define Head Area option is grayed out with DoseRight Index (DRI) on, review
the dose levels displayed on the User Interface, confirm and adjust the dose settings to
appropriate levels before executing the scan as instructed in the IFU.

Consignees were also instructed to complete and return the response form, to circulate the Urgent Medical Device Correction Letter to all users of the affected device so that they are aware of the issues, and retain the letter with affected system(s) until a solution is installed
on each system; ensure the letter is in a place likely to be seen/viewed.

Philips will contact each consignee to schedule a time for a Philips Field Service Engineer (FSE) to visit each site and install the solution to resolve the issues (reference FCO72800830). |
| Quantity in Commerce | 3 systems |
| Distribution | Worldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands. |
| Total Product Life Cycle | TPLC Device Report |

| 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. | |

| 510(K) Database | 510(K)s with Product Code = JAK |