Philips North America Llc — Class II: Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;
Philips North America Llc has initiated a Class II recall for Achieva 3.0T systems due to a software defect that terminates examinations during image reconstruction. This occurs when manual adjustments to scan parameters cause reconstruction requirements to exceed available system memory.
This affects users of Philips Achieva 3.0T systems (Model Numbers 781177, 781277, 781278, 781344, 781345), as well as clinical engineering and radiology departments responsible for device maintenance and operation.
The unexpected termination of an examination during image reconstruction suggests a failure in software error handling or resource management. For regulatory and QA teams, this highlights the risks associated with manual parameter overrides that may bypass system safeguards. The issue likely necessitates a software update or clear instructional constraints to prevent mid-procedure system failures, which could impact clinical workflow efficiency and patient throughput.
Verify that current scan protocols and manual parameter adjustment workflows do not exceed known system memory limits. Ensure that technical bulletins regarding this software limitation are distributed to all imaging personnel and incorporated into user training modules. Monitor for software patches or system updates intended to resolve this memory management issue.
Class II. Reason: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.. Product: Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;. Firm: Philips North America Llc (Cambridge MA United States). Status: Ongoing.
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