Philips recalled 112 ALLURA Xper FD10/10 imaging systems nationwide in the United States and internationally after reports that X-ray imaging may not start or may intermittently stop when using the wired foot switch. The defect affects system codes 722005, 722011, and 722027. Healthcare providers should stop using the devices and follow Philips recall instructions.
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter
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Product: ALLURA Xper FD10/10 imaging system System Codes: 722005, 722011, 722027 Quantity recalled: 112 units Distribution: Domestic nationwide in the United States; International distribution in Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Côte d’Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji,
X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. This could lead to missed or delayed imaging during patient procedures.
No injuries or incidents have been reported.
1. Stop using the device immediately. 2. Contact Philips Medical Systems Nederland B.V. or your healthcare provider for instructions. 3. Follow the recall instructions provided by the manufacturer. 4. Seek remediation and watch for any manufacturer communications. 5. Refund or replacement information is provided through the manufacturer.
Manufacturer: Philips Medical Systems Nederland B.V. Recalls communications are sent by letter. For information, contact the manufacturer or your healthcare provider. FDA enforcement page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1662-2026
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