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Sonesta F3
Sonesta Medical AB · Model F3-230V · UDI-DI 07350006950148
10
510(k) clearances
762
Adverse events (1 deaths)
26
Recalls
23
Facilities
Description
The F3 is a unique procedure table designed for full fluoroscopic imaging of the urinary tract during video Urodynamics procedures, with carbon-fiber support for use with a C-arm. The table has been developed to ensure optimal patient comfort, while focusing on facilitating the positioning of the patient safely and precisely during video fluoroscopy or urology examinations and procedures.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-22 | Sonesta Medical AB | Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping. |
| 2019-12-30 | Philips North America, LLC | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible |
| 2019-05-02 | Oakworks Inc | Table assembly error with incorrect actuators for the lateral and longitudinal table movements |
| 2019-02-28 | Philips North America, LLC | The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user. |
| 2018-03-26 | Philips Medical Systems Nederlands | The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotat |
| 2017-07-31 | Oakworks Inc | The foot control used on the OAKWORKS Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR301, CFUR401 and CFLU401 Imaging Tables can become lodged under the base or under the |
| 2017-02-27 | LIEBEL-FLARSHEIM COMPANY LLC | Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes |
| 2017-02-06 | GE Healthcare, LLC | Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator. |
| 2016-11-21 | GE Healthcare, LLC | GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix, Prestige VH, Prestige SI, RFX/SFX, Legacy, Precision 500D, ADVANTX and |
| 2016-07-19 | Philips Electronics North America Corporation | The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.