Model Number 40KWFXPLUS.889, Mobile X-ray system Class II

Reason: 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.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
Model Number 40KWFXPLUS.005, Mobile X-ray system Class II

Reason: 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.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
Model Number 40KWFXPLUS.004, Mobile X-ray system Class II

Reason: 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.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
Model Number 40KWFXPLUS.002, Mobile X-ray system Class II

Reason: 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.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
Model Number 40KWFXPLUS, Mobile X-ray system Class II

Reason: 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.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
Model Number 40KW-FX.899, Mobile X-ray system Class II

Reason: 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.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
Model Number 40KWFX, Mobile X-ray system Class II

Reason: 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.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system Class II

Reason: 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.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30) Class II

Reason: 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.

SEDECAL SA 20250610 Ongoing
Distributed: US: CA, IL, and NJ
Zenition 50; Product Number (REF): 718096; Interventional fluoroscopic x-ray system Class II

Reason: Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 20250929 Ongoing
Distributed: Distribution US states of MO and TX; Belgium, Canada, Fiji, Germany, India, Malaysia, Mexico, Morocco, South Africa, South Korea, Thailand, United Kingdom, and Uzbekistan.
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Data provided by openFDA