Ferno-Washington Inc — Class II: Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretcher
Ferno-Washington Inc has initiated a Class II recall for the Power F2 Powered Fastening System due to a firmware issue that causes intermittent loss or degradation of powered functionality when paired with compatible stretchers. This malfunction may lead to the system failing to operate in powered mode or exhibiting reduced performance, potentially causing delays in patient transport.
This recall affects Ferno-Washington Inc, healthcare providers, and emergency medical services using the Power F2 Fastening System (Item No. 0567093) in conjunction with Power X2 Stretchers (Item Nos. 0015816 and 0015821).
A firmware-driven failure in a powered fastening system presents a risk of operational delay during critical patient transport. From a regulatory perspective, this emphasizes the importance of software/firmware verification and validation (V&V) for interconnected hardware. The intermittent nature of the issue suggests a potential race condition or compatibility edge case that was not captured during initial testing.
Regulatory and QA teams should ensure that field service teams are prepared to address firmware updates or replacements. Inventory should be audited to identify affected Item Numbers (0567093, 0015816, 0015821) and internal CAPA procedures should be initiated to track the resolution of the firmware defect.
Class II. Reason: Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to the system not operating in powered mode, or exhibiting reduced powered performance. Issue may result in interruption or delay in patient transport.. Product: Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821. Firm: Ferno-Washington Inc (Wilmington OH United States). Status: Ongoing.
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