FDA DevicesClass II
Philips Spectral CT on Rails. Model Number: 728334.
Published: April 22, 2026Recall ID: Z-1825-2026Category: devicesCountry: US
Reason for Recall / Hazard
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? <Yes> or <No> 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.
Product Description & Identification
Philips Spectral CT on Rails. Model Number: 728334.
Additional Source Details
| Field | Value |
|---|---|
| City | Cambridge |
| State | MA |
| Event id | 98588 |
| Address 1 | 222 Jacobs St |
| Address 2 | N/A |
| Code info | Model Number: 728334. UDI: (01)00884838103627(21)1005, (01)00884838103627(21)1006, (01)00884838103627(21)1007. Software Version Number: 5.1.X. Serial Numbers: 1005, 1006, 1007. |
| Postal code | 02141-2289 |
| Report date | 20260422 |
| Product type | Devices |
| Product quantity | 3 systems |
| 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? <Yes> or <No> 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260307 |
| Initial firm notification | Letter |
| Center classification date | 20260416 |
Overview
- Recalling FirmPHILIPS MEDICAL SYSTEMS
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the states of Minnesota and the countries of France and Netherlands.