RADPRO MOBILE, Mobile X-ray system
FDA device recall Z-0281-2026 · posted 2025-10-23 · Open, Classified
Recall details
- Recalling firm
- SEDECAL SA
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- IZL
- Quantity affected
- 24 units
- Distribution
- US: CA, IL, and NJ
- Date initiated
- 2025-06-10
- Date posted
- 2025-10-23
- Location
- Algete, Spain
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR (K161345) | Sedecal., Sa. | 2016-07-06 |