Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Pending LLM rewrite. Source: FDA_DEVICE Z-0265-2026.
- Product
- Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
- Category
- Medical Device
- Distribution
- 3 states
Manufacturer
53 recalls in our database name SEDECAL SA as the manufacturing or recalling firm.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Pending LLM rewrite. Source: FDA_DEVICE Z-0265-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0280-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0246-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0261-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0263-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0272-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0244-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0267-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0257-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0279-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0258-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0264-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0281-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0252-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0270-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0285-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0260-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0268-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0271-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0255-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-0277-2026.
SEDECAL SA is recalling 636 Battery Mobile X-ray Unit EASY MOVING models worldwide due to potential interference with the anti-fall system.
The MobileDiagnost wDR portable X-ray system may move unexpectedly if excessive liquid is used during cleaning. This affects 851 devices distributed nationwide.
Sedecal SA is recalling 845 Sedecal X Optima URS diagnostic x-ray systems after parts fell off the equipment, creating a safety risk to patients and users. The affected units were distributed in Alabama, Florida, and North Carolina.
SEDECAL SA is recalling 1,061 wDR 2.2 Mobile Digital Diagnostic X-Ray Systems due to a software login issue that may prevent users from logging in. The affected units are distributed in the United States and over 70 countries internationally.