Philips Healthcare Computed Tomography X-Ray System — Class II medical device recall Z-1003-2013
Terminated recall by Philips Healthcare Inc., reported 2013-04-24, distributed nationwide. Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and rec
| Recall number | Z-1003-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Inc., Andover, MA, United States |
| Recall initiated | 2010-04-05 |
| Classified | 2013-04-17 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2021-03-08 |
| Distributed | Nationwide (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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1003-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.