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IMAGE DIAGNOSTICS INC
IMAGE DIAGNOSTICS, INC. · Model 100RT · UDI-DI 00850977007331
10
510(k) clearances
762
Adverse events (1 deaths)
26
Recalls
22
Facilities
Description
IDI,TABLE,VERT.-TILT-ROLL TABLETOP MOVEMENT,PAIN MANAGEMENT-GENERAL SURGERY-IMAGING,ASPECT 100RT,120V,TABLETOP WITH FACIAL CUTOUT,#A100-2644
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.