Philips Medical Systems (Cleveland) Inc Recall: Ingenuity Core 128, (Code 728323) Intended
Philips Medical Systems (Cleveland) Inc Recall: Ingenuity Core 128, (Code 728323) Intended is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Philips Medical Systems (Cleveland) Inc; Product: Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer rec
| Recalling firm | Philips Medical Systems (Cleveland) Inc |
|---|---|
| Product | 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. |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts |
| Recall initiated | 20171110 |
| Recall number | Z-0391-2018 |
| Category | device |
| State | OH |
| Country | United States |
$29/mo
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