The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0242-2026·Announced 2025-10-29

Digital diagnostic X-ray systems recalled with reminder about improper cleaning

Sedecal is recalling 56 SM-40HF-B-D-KM (AeroDR X30) mobile digital diagnostic X-ray systems after emailing consignees to remind users that the equipment is not water-resistant.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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

Sedecal Mobile Digital Diagnostic X-Ray Systems, model SM-40HF-B-D-KM (AeroDR X30), are 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 56 units carrying UDI/DI 08436046002593, with serial numbers including G-81478, G81924, G84618, G87981, G88006, G88007, G87866 and G84607, 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
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
Manufacturer
SEDECAL SA
Category
Medical Device — Mobile X-ray
Hazard
Affected units
56

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 08436046002593
  • Serial Numbers: G-81478
  • G81924
  • G84618
  • G87981
  • G88006
  • G88007
  • G87866
  • G84607
  • G86618
  • G88041
  • G87427
  • G80991
  • G-81936
  • G86688
  • G-82904
  • G86360
  • G84340
  • G86372
  • G81471

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 →

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