Philips EPIQ ultrasound systems recalled for possible software errors
Philips is recalling EPIQ and Affiniti diagnostic ultrasound systems with the Auto Measure option running software versions 9.0 or 9.0.1. The software may show incorrect values in the results box, final report, or both, which could mean measurements need to be taken again. No injuries have been reported, and 995 systems are affected.
From the FDA notice · Read the official notice ↗ · All Philips recalls
What to do
- Have clinicians re-check any measurements taken with Auto Measure on these systems before relying on those values.
- Identify affected systems by the model numbers 795117, 795118, 795190, 795200, 795201, 795204, 795205, 795208, 795210, 795218, 795231, 795232 and 795234, and by the serial numbers and UDI codes in the notice.
- The notice doesn't say how to get a fix; contact Philips Ultrasound, LLC for guidance.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Philips EPIQ series and Affiniti series Diagnostic Ultrasound Systems with the Auto Measure licensed Option with Software Versions 9.0 and 9.0.1. Model Numbers: 795117, 795118, 795190, 795200, 795201, 795204, 795205, 795208, 795210, 795218, 795231, 795232 and 795234 The intended use of EPIQ Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body.
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 995 systems
- Illnesses reported
- None reported
- Manufactured in
- 22100 Bothell Everett Hwy, Bothell, Washington, United States
- Classification
- Class II
- Recall number
- Z-0428-2027
In the FDA's words
- Description
- Philips EPIQ series and Affiniti series Diagnostic Ultrasound Systems with the Auto Measure licensed Option with Software Versions 9.0 and 9.0.1. Model Numbers: 795117, 795118, 795190, 795200, 795201, 795204, 795205, 795208, 795210, 795218, 795231, 795232 and 795234 The intended use of EPIQ Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body. Due to software issues that may display incorrect values in the results box, final report, or both, potentially leading to the need for re-measureemtn of values. Philips EPIQ series and Affiniti series Diagnostic Ultrasound Systems with the Auto Measure licensed Option with Software Versions 9.0 and 9.0.1. Model Number / Serial Number / UDI code: 795117 US121B0844 (01)00884838097841(21)US121B0844 795118 US914D0576 (01)00884838056244(21)US914D0576 795190 US121R0746 (01)00884838097148(21)US121R0746 795190 US121R0747 (01)00884838097148(21)US121R0747 795190 US121R0748 (01)00884838097148(21)US121R0748 795190 US121R0749 (01)00884838097148(21)US121R0749 795190 US121R0750 (01)00884838097148(21)US121R0750 795190 US121R0751 (01)00884838097148(21)US121R0751 795190 US121R0752 (01)00884838097148(21)US121R0752 795190 US121R0753 (01)00884838097148(21)US121R0753 795190 US121R0754 (01)00884838097148(21)US121R0754 795190 US121R0794 (01)00884838097148(21)US121R0794 795190 US121R0795 (01)00884838097148(21)US121R0795 795190 US121R0796 (01)00884838097148(21)US121R0796 795190 US121R0797 (01)00884838097148(21)US121R0797 795190 US121R0798 (01)00884838097148(21)US121R0798 795190 US121R0799 (01)00884838097148(21)US121R0799 795190 US121R0800 (01)00884838097148(21)US121R0800 795190 US121R0801 (01)00884838097148(21)US121R0801 795190 US121R0802 (01)00884838097148(21)US121R0802 795190 US121R0803 (01)00884838097148(21)US121R0803 795190 US121R0804 (01)00884838097148(21)US121R0804 795190 US121R0897 (01)00884838097148(21)US121R0897 795190 US121R1936 (01)00884838097148(21)US121R1936 795190 US121R2004 (01)00884838097148(21)US121R2004 795190 US121R2005 (01)00884838097148(21)US121R2005 795190 US122R0287 (01)00884838106598(21)US122R0287 795190 US122R0338 (01)00884838106598(21)US122R0338 795190 US122R0339 (01)00884838106598(21)US122R0339 795190 US122R0340 (01)00884838106598(21)US122R0340 795190 US221R0237 (01)00884838097148(21)US221R0237 795190 US321R0826 (01)00884838097148(21)US321R0826 795190 US321R1074 (01)00884838097148(21)US321R1074 795190 US321R1075 (01)00884838097148(21)US321R1075 795190 US321R1076 (01)00884838097148(21)US321R1076 795190 US321R1077 (01)00884838097148(21)US321R1077 795190 US321R1078 (01)00884838097148(21)US321R1078 795190 US321R1079 (01)00884838097148(21)US321R1079 795190 US321R1782 (01)00884838097148(21)US321R1782 795190 US421R1110 (01)00884838101043(21)US421R1110 795190 US421R1111 (01)00884838101043(21)US421R1111 795190 US521R1598 (01)00884838101043(21)US521R1598 795190 US621R1651 (01)00884838101043(21)US621R1651 795190 US721R0774 (01)00884838101043(21)US721R0774 795190 US921R1236 (01)00884838106598(21)US921R1236 795190 US921R1238 (01)00884838106598(21)US921R1238 795190 US921R1304 (01)00884838106598(21)US921R1304 795190 USD20R0807 (01)00884838097148(21)USD20R0807 795190 USD21R0743 (01)00884838106598(21)USD21R0743 795190 USD21R0755 (01)00884838106598(21)USD21R0755 795190 USD21R0785 (01)00884838106598(21)USD21R0785 795190 USD21R0891 (01)00884838106598(21)USD21R0891 795190 USD21R0892 (01)00884838106598(21)USD21R0892 795190 USD21R0902 (01)00884838106598(21)USD21R0902 795190 USD21R1028 (01)00884838106598(21)USD21R1028 795190 USD21R1095 (01)00884838106598(21)USD21R1095 795190 USD21R1141 (01)00884838106598(21)0023483467 795190 USD21R1142 (01)00884838106598(21)USD21R1142 795190 USD21R1143 (01)00884838106598(21)USD21R1143 795190 USD21R1144 (01)00884838106598(21)USD21R1144 795190 USD21R1145 (01)00884838106598(21)USD21R1145 795190 USD21R1212 (01)00884838106598(21)USD21R1212 795190 USD21R1213 (01)00884838106598(21)USD21R1213 795190 USD21R1218 (01)00884838106598(21)USD21R1218 795190 USD21R1260 (01)00884838106598(21)USD21R1260 795190 USD21R1341 (01)00884838106598(21)USD21R1341 795190 USD21R1342 (01)00884838106598(21)USD21R1342 795190 USD21R1462 (01)00884838106598(21)USD21R1462 795190 USD21R1619 (01)00884838106598(21)USD21R1619 795190 USD21R1620 (01)00884838106598(21)USD21R1620 795190 USD21R1621 (01)00884838106598(21)USD21R1621 795190 USD21R1636 (01)00884838106598(21)USD21R1636 795190 USD21R1686 (01)00884838106598(21)USD21R1686 795190 USD21R1756 (01)00884838106598(21)USD21R1756 795190 USD21R1757 (01)00884838106598(21)USD21R1757 795190 USD21R1758 (01)00884838106598(21)USD21R1758 795190 USD21R1995 (01)00884838106598(21)USD21R1995 795190 USD21R1997 (01)00884838106598(21)USD21R1997 795190 USN20R1089 (01)00884838097148(21)USN20R1089 795190 USN20R1124 (01)00884838097148(21)USN20R1124 795190 USN20R1207 (01)00884838097148(21)USN20R1207 795190 USN20R1208 (01)00884838097148(21)USN20R1208 795190 USN21R0342 (01)00884838106598(21)USN21R034
- Hazard
- Due to software issues that may display incorrect values in the results box, final report, or both, potentially leading to the need for re-measureemtn of values.
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