Philips BuckyDiagnost Radiographic — Class II medical device recall Z-1450-2013
Terminated recall by Philips Healthcare Inc., reported 2013-06-26, distributed nationwide. An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) records shows tabl
| Recall number | Z-1450-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Healthcare Inc., Andover, MA, United States |
| Recall initiated | 2013-01-16 |
| Classified | 2013-06-17 |
| Reported by FDA | 2013-06-26 |
| Terminated | 2013-10-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 116 units |
| Reason classes | specification failure |
| Serial numbers | 334584, 345869, 349805, 352617, 352645, 355617, 356954, 361021, 361526, 362217, 362252, 362429, 363545, 363678, 363802, 364214, 364816, 366090, 366510, 367504, 370290, 370643, 372845, 373506, 375957/SN07000650 and 90 more |
| Model numbers | 704031, 704032, 704035, 704060, 704062 |
Product
Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics
Reason for recall
An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) records shows table height measurements out of specification with the consequence of potential system mis-alignment
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-1450-2013. 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.