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Action®
ACTION PRODUCTS, INC. · Model Bolx I · UDI-DI 00089904005175
1
510(k) clearances
78
Adverse events (1 deaths)
12
Recalls
20
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-01 | Carl Zeiss Meditec AG | Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications. |
| 2023-02-10 | Sensus Healthcare, Inc. | When the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient. |
| 2022-04-27 | Xstrahl Limited | There is a potential compatibility issue with the systems and replacement treatment applicators. |
| 2021-08-27 | Xstrahl Limited | Base plate may detach from the main body of the treatment applicator. |
| 2021-04-26 | Xstrahl Limited | If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages |
| 2017-08-30 | Carl Zeiss Meditec AG | The device had an incorrect printed calibration value on the calibration certificate. |
| 2012-10-25 | Carl Zeiss Meditec, Inc. | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| 2012-10-25 | Carl Zeiss Meditec, Inc. | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| 2012-10-25 | Carl Zeiss Meditec, Inc. | A manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve. |
| 2011-07-01 | Carl Zeiss Meditec, Inc. | Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to be Triethylene Glycol, |
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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.