Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
Reported: October 29, 2025 Initiated: June 10, 2025 #Z-0242-2026
Product Description
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
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.
Details
- Recalling Firm
- SEDECAL SA
- Units Affected
- 56 units
- Distribution
- US: CA, IL, and NJ
- Location
- Algete
Frequently Asked Questions
What product was recalled? ▼
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30). Recalled by SEDECAL SA. Units affected: 56 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 29, 2025. Severity: Moderate. Recall number: Z-0242-2026.
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