Recall Z-1754-2024 · IZL System, X-Ray, Mobile
SEDECAL SA
Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (AeroDR X30); i. SM-50HF-B-D-KM (AeroDR X30); j. MobileDiagnost wDR.
| Date | May 2, 2024 (initiated Jan 22, 2024) |
| Status | Open, Classified |
| Reason | Potential interference with the anti-fall system. |
| Root cause | Component design/selection |
| Action | The firm issued letters dated 1/22/2024 via email to notify their distributor customers of the potential problem that could occur and the availability of a service kit that corrects the anomaly. The letter informs the distributor that a service kit has been created to install a new cable without the interference point in all of the installed bases of the devices. This kit contains parts for updating the parachute safety system making it similar to the one in production for the current product release. The entire installed base of Mobile System 3.1 must be inspected using the provided instru |
| Quantity | 636 devices |
| Distribution | Worldwide distribution - US Nationwide in the states of CA, IL, NJ, and areas yet to be identified by Philips Medical Systems DMC GmbH, Hamburg, Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161345 | RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR Sedecal., Sa., Jul 6, 2016 |