PARCA eNews – Nov. 7, 2019 – The FDA has issued a Class I recall for the Philips Medical Systems Forte Gamma Camera System manufactured between 1998 and 2008.
A Class I recall is the most serious recall type due to the potential for serious injury or death. In this case, a defect has been discovered that can allow an internal component to fail resulting in the gamma camera detector dropping. The 660 pound component could crush or trap a patient resulting in serious injury or death.
In a letter to Philips customers, facilities and distributors are advised to discontinue using the device until further notice.
Customers who have questions or need additional information or support regarding this recall should contact their local Philips representative in the Customer Care Solutions Center at 1-800-722-9377.
Source: FDA press release
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