IntelliSpace PACS 4 — Class II medical device recall Z-2338-2020
Completed recall by Philips Healthcare Informatics, Inc., reported 2020-06-17, distributed nationwide. Images may potentially become corrupt while using the system.
| Recall number | Z-2338-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Informatics, Inc., Pleasanton, CA, United States |
| Recall initiated | 2019-04-19 |
| Classified | 2020-06-10 |
| Reported by FDA | 2020-06-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BR, CA, GB, IE, NZ |
| Quantity | 26 units |
| UPC / GTIN / UDI-DI | 00884838074781 |
Product
IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
Reason for recall
Images may potentially become corrupt while using the system.
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-2338-2020. 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.