Intended for both adult and pediatric patients for taking diagnostic… — Class II medical device recall Z-0508-2015
Terminated recall by Philips Medical Systems, Inc., reported 2014-12-24, distributed nationwide. In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended expo
| Recall number | Z-0508-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems, Inc., Andover, MA, United States |
| Recall initiated | 2014-04-08 |
| Classified | 2014-12-16 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2018-05-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FI, FR, GB, IE, IQ, IT, JO, KR, MX, NL, NO, NZ, OM, PA, PT, RU, SA, SE, SG, TH, ZA |
| Quantity | 247 in |
| Serial numbers | SN11000001, SN11000002, SN11000003, SN11000004, SN11000005, SN11000006, SN11000007, SN11000008, SN11000009, SN11000010, SN11000011, SN11000012, SN11000013, SN11000014, SN11000015, SN11000016, SN11000017, SN11000018, SN11000020, SN11000021, SN11000022, SN11000023, SN11000024, SN11000025, SN11000026 and 411 more |
Product
Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.
Reason for recall
In special cases, during the start-up of the current model of MobileDiagnost wDR(WmDR 1.1), an unintended exposure could occur.
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-0508-2015. 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.