Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0261-2026.
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
- Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system
- 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 (10)
- UDI/DI 08436046001114
- Serial Numbers: G24948
- G25512
- C25673
- 25901
- G25771
- G26990
- G25506
- G22189
- G30240.
Distribution
Distributed in 3 states:
- CA
- IL
- NJ
Related recalls
Same category
- SevereABIOMED Insertion Kit heart pump accessories introducer sheath leakage
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- LowRio II Nasal Pillows Interface Packaging and Labeling Discrepancy Recall
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella Introducer Kit recalled for potential fluid leakage
FDA (Devices) · 2026-07-22
- SevereABIOMED Impella CP Heart Pump Set Introducer Sheath Leakage Risk
FDA (Devices) · 2026-07-22