FDA Device recall Z-2109-2016
Big Bore Oncology tomography X-ray system scanner, model number 728243
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of Big Bore Oncology tomography X-ray system scanner, model number 728243 by Philips Medical Systems Cleveland, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2109-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-14 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | n/a |
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
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.
Identifiers
| code_info | Big Bore Oncology System Code 728243; Serial numbers: 75002, 75003, 75004, 75005, 75006, 75007, 75008, 75009, 75010,…Big Bore Oncology System Code 728243; Serial numbers: 75002, 75003, 75004, 75005, 75006, 75007, 75008, 75009, 75010, 75011, 75012, 75014, 75015, 75016, 75017, 75018, 75019, 75020, 75021, 75022, 75023, 75024, 75025, 75026, 75030, 75032, 75035, 75036, 75037, 75040, 75042, 75044, 75047, 75048, 75049, 75051, 75053, 75060, 75064, 75100, 75102, 75104, 75105, 750111, 750114 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2109-2016%22
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