Sedecal Mobile Digital Diagnostic X-Ray Systems recall
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
Why was Sedecal Mobile Digital Diagnostic X-Ray Systems 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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, G86358, G86361, G87844, G87845, G85932, G86683, G84620, G84621, G85914, G87409, G87434, G84326, G84325, G-81925, G81923, G-81935, G84619, G-81934, G87426, G81002, G86686, G84339, G88042, G-82885, G-82887, G-82905, G84327, G85788, G85913, G85801, G86356, G87867, G88008, G87425, G86659, G88009, G87846.
- Product
- Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
- Recalling firm
- SEDECAL SA
- Quantity
- 56 units
- Distribution
- US: CA, IL, and NJ
- Recall date
- October 29, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)