FDA Device recall Z-1003-2013
Philips Healthcare Computed Tomography X-Ray System
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of Philips Healthcare Computed Tomography X-Ray System by Philips Healthcare, citing philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parame….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1003-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2010-04-05 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Healthcare |
| Distribution | US |
Product
Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.
Reason
Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parameters stated.
Identifiers
| code_info | Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big…Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore, Precedence SPECT/CT, Brilliance CT (6, 10,16, 16P, 40, 64, and Big Bore), Brilliance iCT, Brilliance iCT SP |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Philips Healthcare
- Incisive CT, software version 5.0
FDA Device · Class II · 2023-10-11 · Philips Healthcare - Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
FDA Device · Class II · 2022-04-13 · Philips Healthcare - Azurion systems with software release R2.0.x
FDA Device · Class II · 2022-03-30 · Philips Healthcare - CombiDiagnost R90 is multi-functional general R/F systems
FDA Device · Class II · 2021-12-01 · Philips Healthcare - Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
FDA Device · Class II · 2021-12-01 · Philips Healthcare
All Philips Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1003-2013%22
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