Z-0271-2026Class II
Model Number SM-40HF-B-D-C; 40KW 70C, 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 70C, 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-0271-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Sedecal S.A.
- Product
- Model Number SM-40HF-B-D-C; 40KW 70C, 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
- 181 units
- Distribution
- US: CA, IL, and NJ
- Product codes and lots
- UDI/DI 08436046001510, Serial Numbers: D11-40KW-F, G36689, G37293, G38198, G38657, G38385, G37687, G36643, G41114, G36137, G36761, G36272, G37188, G37359, G37456, G38178, G62012, G62059, G62892, G62943, G41083, G41100, G36217, G36537, G60066, G61812, G61812, G63322, G40016, G41203, G41222, G60061, G60063, G60064, G36732, G36751, G41119, G62480, G60418, G61707, G65172, G39639, G41104, G36526, G36601, G37129, G37209, G41244, G62015, G40024, G62828, G60429, G61818, G61873, G60065, G61786, G37430, G36148, G39650, G64186, G65400, G64854, G62626, G62660, G62684, G62687, G62747, G62750, G62762, G62938, G63484, G62804, G64206, G64813, G64179, G62500, G62502, G62565, G62690, G62860, G62867, G62883, G62891, G62947, G36222, G60415, G60070, G37646, G61715, G39589, G37466, G38292, G38173, G38058, G38293, G60069, G62816, G63335, G36244, G36492, G37442, G38613, G40124, G40211, G38190, G40199, G62567, G39809, G38287, G37196, G41256, G61872, G62029, G64891, G62682, G62900, G61311, G37239, G38279, G37678, G38076, G61307, G39808, G40133, G62821, G64883, G60058, G60062, G61867, G37676, G40203, G37422, G62815, G36468, G37413, G40216, G41058, G41066, G63212, G41267, G40227, G60430, G63318, G63328, G63333, G41108, G41109, G61716, G60518, G60652, G61356, G60520, G60597, G39800, G39801, G60582, G39657, G62030, G65393, G65395, G39782, G39791, G61706, G61795, G62053, G62062, G62011, G64512, G64520, G65289, G60576, G60606, G60631, G61339, G39465, G61333, G61337, G38629, G62511, G41218, G60635.
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
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