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.
- Recall Initiated
- January 22, 2024
- Posted
- May 2, 2024
- Recall Number
- Z-1754-2024
- Quantity
- 636 devices
Reason for Recall
Potential interference with the anti-fall system.
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.
Lot / Code Info
All serial numbers of model 3.1 Battery Mobile X-ray Unit EASY MOVING are affected. Following are the UDI numbers involved: a. SM-20HF-Batt - UDI-DI 08436046001497 b. SM-32HF-Batt - UDI-DI 08436046001503 c. SM-40HF-Batt - UDI-DI 08436046001510; d. SM-50HF-Batt - UDI-DI 08436046001527; e. SM-40-HF-B-D-VIR - UDI-DI 08436046002166; f. SM-20HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002579; g. SM-32-HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002586; h. SM-40HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002593; i. SM-50HF-B-D-KM(AeroDR X30) - UDI-DI 08436046002609; j. MobileDiagnost wDR - UDI-DI 08436046002357.
Root Cause
Component design/selection
Action Taken
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 instructions in SIN 23-08-22 and the kit installed using the instructions in SIN 23-04-10 immediately if the cable could interfere with the parachute system. If no damage is found during the inspection, the kit can be installed in the next cable replacement scheduled according to the Service Manual instruction. An Acknowledgment Form was enclosed for completion and return as soon as possible that the distributor understands the letter. An Acknowledgment of Action Implemented was also enclosed for completion and return as soon as possible.