Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
Pending LLM rewrite. Source: FDA_DEVICE Z-0242-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
The recalled product
- Product
- Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
- Manufacturer
- SEDECAL SA
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI/DI 08436046002593
- Serial Numbers: G-81478
- G81924
- G84618
- G87981
- G88006
- G88007
- G87866
- G84607
- G86618
- G88041
- G87427
- G80991
- G-81936
- G86688
- G-82904
- G86360
- G84340
- G86372
- G81471
Distribution
Distributed in 3 states:
- CA
- IL
- NJ
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