Big Bore Oncology tomography X-ray system scanner — Class II medical device recall Z-2109-2016
Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-07-06. Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rat
| Recall number | Z-2109-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States |
| Recall initiated | 2016-06-14 |
| Classified | 2016-06-30 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2018-07-02 |
| Countries outside the US | BE, CN, DE, EG, ES, GB, IN, KR, NG, PE, SE, SG, TH, TW |
| Quantity | 47 units |
| Serial numbers | 75002, 75003, 75004, 75005, 75006, 75007, 75008, 75009, 75010, 75011, 750111, 750114, 75012, 75014, 75015, 75016, 75017, 75018, 75019, 75020, 75021, 75022, 75023, 75024, 75025 and 20 more |
| Model numbers | 728243 |
Product
Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
Reason for recall
Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel.
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-2109-2016. 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.