Philips Medical Systems (Cleveland) Inc: Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angl

Is my product affected?

Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.

• UPC 00884838059474

Check against the official notice below — it lists the full affected range.

What happened

Philips Medical Systems is recalling three Ingenuity Core 128 CT imaging systems (Code 728323) due to fastener assembly concerns. The company identified that certain fasteners on these systems cannot be confirmed to have been torqued to the manufacturer's specifications. If these fasteners were not properly tightened and a failure occurs during system operation, parts may become loose, which could potentially cause harm.

The affected systems have serial numbers 320394, 320395, and 336286, and were distributed worldwide including to four locations in the United States (one military facility), and to facilities in Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and the United Kingdom. The source record does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.

Details from the source

Reason for recall: Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm. Distribution: Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts Quantity: 3 Lot/code info: Code 728323, SN # 320394, UDI: (01)00884838059474(21)320394; 320395, UDI: (01)00884838059474(21)320395; and 336286.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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