FDA recall Z-1754-2024

Product

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.

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.

Key facts

Status

Ongoing

Initiation date

2024-01-22

Report date

2024-05-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Algete, Spain

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1754-2024