FDA Medical Device Recalls (openFDA)
SEDECAL SA: Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
- Recall number
- Z-0257-2026
- Recalling firm
- SEDECAL SA
- Product
- Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
- Status
- Open, Classified
- Initiated
- 2025-06-10
- Posted
- 2025-10-23
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- Action
- Sedecal emailed their distributors on 06/10/2025 to remind them 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. on 09/19/2025 the firm issued an Important Safety Notice to its direct consignees via email. This notice initiates Phase 2 of the recall strategy expanding the scope and providing information on stickers to cover gaps around the fine positioning control buttons and a DMC software update that stops unit movement if triggered by a short cicuit or prolonged button press with instructions. Consignees will be contacted by a Sedecal Customer support Service to coordinate the shipment of the necessary conversion kits (quantity and delivery address) to allow upgrading the affected units.
- Quantity
- 6 units
- Distribution
- US: CA, IL, and NJ
- Lot, serial or model codes
- UDI/DI 08436046001510, Serial Numbers: G-33126, G31259, G35641, G35630, G35718, G37357.
- 510(k) numbers
- ["K090322"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 3002495042
- Firm city
- Algete
- Firm state
- not on file
- Firm country
- Spain
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28