Sedecal recalled 1,198 MobileDiagnost wDR 2.2 mobile X-ray systems distributed in California, Illinois and New Jersey. The company reminded users the equipment is not water-resistant and must be cleaned strictly according to the manual. Improper cleaning could have consequences outlined by Sedecal. Health care providers should stop using the device immediately and follow recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SEDECAL SA or your healthcare provider for instructions. Notification method: E-Mail
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The MobileDiagnost wDR 2.2 is a portable X-ray system used by healthcare providers to perform radiographic imaging at patient bedsides or in transport.
The device is not water-resistant. Cleaning must follow the manual. Improper cleaning could cause damage or complex operational issues as outlined by the manufacturer.
This recall is not described as part of a broader industry pattern.
Hospitals and clinics using the device must review cleaning protocols and may experience downtime while awaiting remediation.
On the device label, in the user manual, and the FDA recall page linked to the notice.
Not specified. Remediation steps depend on Sedecal instructions and regulatory guidance.
Keep the recall notice, serial numbers, and all correspondence with Sedecal SA and healthcare providers.
Model numbers: REF 9890-010-89522; UDI/DI 08436046002357. Serial numbers include: SN11000007, SN13000099, SN13000100, SN13000101, 13000079, SN13000080, SN13000082, SN13000062, SN13000059, SN13000063, SN13000061, 13000067, 13000076, SN13000089, SN13000103, 13000085, SN13000146, 13000094, 13000092. Where sold: United States (California, Illinois, New Jersey). When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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