FDAFDA · Food and drugs·Recall number Z-0391-2018
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.
Published January 24, 2018 · Recall initiated: November 10, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
- Lot
- Code 728323, SN # 320394, UDI: (01)00884838059474(21)320394; 320395, UDI: (01)00884838059474(21)320395; and 336286.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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