Philips Xcelera Connect — Class II medical device recall Z-1942-2012
Terminated recall by Philips Healthcare Inc., reported 2012-07-11, distributed nationwide. Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface
| Recall number | Z-1942-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Inc., Andover, MA, United States |
| Recall initiated | 2012-06-14 |
| Classified | 2012-07-05 |
| Reported by FDA | 2012-07-11 |
| Terminated | 2017-03-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, CL, DE, DK, EE, ES, FI, FR, GB, HK, IE, IT, MY, NL, PL, SA, SE, SI, TW, ZA |
| Quantity | 226 units |
Product
Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the connection by serving as a central point for data exchange. The data consists only of demographic patient information, schedules, textual information and text reports.
Reason for recall
Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface
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-1942-2012. 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.