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الاثنين - ذو القعدة 21, 1446
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SA-03-03-25-799
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اسم الجهاز الطبي
Welch Allyn non-automated blood pressure gauges
الأجهزة المتأثرة
Please refere to the attachment A.
الممثل المعتمد
Baxter AG
سبب المشكلة
Welch Allyn non-automated blood pressure gauges may not meet leak and accuracy specifications following exposure to high temperature storage. Baxter recommends storing the devices at a temperature not exceeding the operating temperature of 40°C/104°F.
الإجراء التصحيحي
1. Customers may continue to use Welch Allyn non-automated blood pressure gauges if the device is calibrated. To check that the device is calibrated, please perform the following quick check of calibration as described in the product Instructions for Use. - At zero pressure, make certain the pointer is within the oval surrounding the zero-pressure gradation on the dial. If the pointer is fully outside of the tolerant zone (the darkly shaded area in the illustration) the device may need calibration. Although an unpressurized reading of zero does not guarantee accuracy at all scale points, failure of the pointer to indicate zero (±3 mm Hg) is an obvious sign of error. 2. For further information related to this product, visit the following link to the Instructions for Use: www.hillrom.com/content/dam/hillrom-aem/us/en/sap-documents/LIT/80025/80025959LITPDF.pdf Manufacturer action: Instructions and correction.
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