The Recall Desk
ModerateFDA (Devices)·Z-0281-2026·Announced 2025-10-29

RadPro mobile X-ray systems recalled with water resistance cleaning reminder

Sedecal is recalling 24 RadPro 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 RADPRO MOBILE X-ray system 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 24 units carrying UDI/DI 08436046002166, with serial numbers including G30567, G31256, G32581, G30250, G28320, G30902, G29864, G35389 and G30960, 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
RADPRO MOBILE, Mobile X-ray system
Manufacturer
SEDECAL SA
Category
Medical Device — Mobile X-ray
Hazard
Affected units
24

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 (20)

  • UDI/DI 08436046002166
  • Serial Numbers: G30567
  • G31256
  • G32581
  • G30250
  • G28320
  • G30902
  • G29864
  • G35389
  • G30960
  • G33238
  • G31252
  • G33708
  • G30771
  • G33634
  • 31412
  • 31480
  • G33004
  • G33112
  • G33585

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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