The Recall Desk
ModerateFDA (Devices)·Z-0284-2026·Announced 2025-10-29

Seventeen mobile X-ray systems recalled with reminder about water resistance limits

Sedecal is recalling 17 SM_40HF_B_D_VIR3 mobile X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 as a precautionary user notification: the record describes a reminder about cleaning instructions rather than a defect, with no reported harm.

Plain-English summary

The Sedecal mobile X-ray system, model SM_40HF_B_D_VIR3, is subject to a recall consisting of a customer notification.

Sedecal sent an email to its consignees reminding 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.

The recall covers 17 units carrying UDI/DI 08436046002166, with serial numbers including G86476, G86632, G86634, G85447, G86619, G85453 and G85461, distributed in California, Illinois and New Jersey. The FDA has classified the action as Class II.

The enforcement record describes a user reminder rather than a device defect, and reports no injuries. Sites should follow the cleaning instructions in the manual.

The recalled product

Product
SM_40HF_B_D_VIR3, Mobile X-ray system
Manufacturer
SEDECAL SA
Category
Medical Device — Mobile X-ray
Hazard
Affected units
17

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

  • UDI/DI 08436046002166
  • Serial Numbers: G86476
  • G86632
  • G86634
  • G85447
  • G86619
  • G85453
  • G85461
  • G86477
  • G86633
  • G87334
  • G87335
  • G87336
  • G87353
  • G86617
  • G87337
  • G85335
  • G85452.

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 46 recalled by SEDECAL SA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 46 products in this recall →

Related recalls

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Same hazard · user notification

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