Z-0277-2026Class II
Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
Sedecal S.A. / initiated 2025-06-10 / Open, Classified / root cause: design
SEDECAL SA began a recall of Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0277-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Sedecal S.A.
- Product
- Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
- Product code
- IZL System, X-Ray, Mobile
- 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.
- Root cause tag
- design
- FDA 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 in commerce
- 142 units
- Distribution
- US: CA, IL, and NJ
- Product codes and lots
- UDI/DI 08436046001510, Serial Numbers: G65281, G60407, G65682, G64582, G64789, G70752, G65384, G65418, G67250, G68470, G70521, G70524, G70913, G70914, G65166, G63507, G64205, G64842, G71447, G65175, G65382, G64793, G64798, G40226, G72434, G65554, G67230, G37280, G65174, G65558, 15033R, G64271, G64713, G64849, G65168, G71272, G71309, G65284, G72955, G65043, G70919, G72429, G72789, G70928, G72776, G72766, G63409, G63418, G64893, G66907, G65588, G65402, G73096, G73131, G71269, G71750, G71762, G71267, G71727, G71732, G71745, G71755, G71761, G66892, G65275, G70922, G73154, G64505, G65744, G73033, G73134, G64941, G63489, G65036, G64256, G72976, G73092, G73145, G64196, G64945, G72412, G73074, G65414, G71726, G71743, G64807, G66872, G67257, G40208, G64885, G38391, G39467, G39818, G65408, G70748, G37108, G6715, G67232, G71277, G71286, G64604, G37406, G40004, G63223, G63224, G63232, G61711, G71271, G71302, G72790, G64500, G65269, G65692, G65290, G65691, G66862, G65283, G64189, G70744, G64812, G70755, G65286, G65266, G72760, G66884, G64601, G71300, G67185, G63495, G64890, G72780, G64607, G63488, G63494, G71285 - NCR1161, G63501, G41245, G64797, G64819, G64855, G72803, G41213.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0242-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0243-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0244-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0245-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0246-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0247-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0248-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0249-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0250-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0251-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0252-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0253-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0254-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0255-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0256-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0257-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0258-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0259-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0260-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0261-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0262-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0263-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0264-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0265-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0266-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0267-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0268-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0269-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0270-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0271-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0272-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0273-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0274-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0275-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0276-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0277-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0278-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0279-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0280-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0281-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0282-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0283-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0284-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0285-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0286-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0287-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.