Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF
Summary
The FDA issued a Class II for Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model nu by SEDECAL SA. Reason: Potential interference with the anti-fall system..
Details
Source
Device Recall
External ID
Z-1754-2024
Action Date
2024-05-08
Status
Ongoing
Category
device
Product Description
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.
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.
Quantity Affected: 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-22
Company
Algete
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 175 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SEDECAL SA has 57 FDA actions in our database, including 53 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SEDECAL SA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SEDECAL SA have FDA actions?
SEDECAL SA has 57 FDA actions in our database, including 53 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1754-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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