EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
Class I - DangerousWhat Should You Do?
- Check if you have this product: TRACE ITEM SERIAL NUMBERS in the UNITED STATES: US713B0171, US713B0207, US813B0017, US813B0018, US813B0019, US813B0020, US813B0022, US813B0023, US813B0024, US813B0025, US813B0122, US813B0123, US813B0125, US813B0127, US813B0128, US813B0129, US813B0131, US813B0132, US813B0134, US813B0135, US813B0233, US813B0234, US813B0235, US813B0236, US813B0237, US813B0238, US813B0239, US813B0240, US813B0423, US813B0424, US813B0425, US813B0426, US813B0427, US813B0428, US813B0429, US813B0430, US813B0431, US813B0432, US813B0433, US813B0434, US913B0033, US913B0034, US913B0035, US913B0036, US913B0037, US913B0038, US913B0039, US913B0040, US913B0057, US913B0060, US913B0061, US913B0062, US913B0063, US913B0064, US913B0065, US913B0066, US913B0106, US913B0107, US913B0108, US913B0109, US913B0110, US913B0111, US913B0112, US913B0113, US913B0144, US913B0176, US913B0201, US913B0256, US913B0257, US913B0350, US913B0363, US913B0364, US913B0365, US913B0366, US913B0367, US913B0368, US913B0369, US913B0380, US913B0384, US913B0395, US913B0396, US913B0397, US913B0398, US913B0399, US913B0400, US913B0401, US913B0402, US913B0409, US913B0441, US913B0444, US913B0445, US913B0446, US913B0447, US913B0503, US913B0522, US913B0614, US913B0615, US913B0616, US913B0618, US913B0619, and USO13B0043. TRACE ITEM SERIAL NUMBERS INTERNATIONAL: US513B0224, US513B0295, US513B0387, US513B0560, US613B0299, US713B0085, US713B0086, US713B0118, US713B0119, US713B0120, US713B0122, US713B0123, US713B0126, US713B0149, US713B0171, US713B0172, US713B0192, US713B0193, US713B0194, US713B0195, US713B0204, US713B0205, US713B0206, US713B0208, US713B0324, US713B0325, US713B0358, US713B0359, US713B0437, US713B0439, US713B0440, US713B0532, US713B0537, US713B0573, US713B0574, US713B0575, US713B0576, US713B0577, US713B0578, US713B0579, US713B0580, US713B0581, US713B0582, US713B0583, US713B0584, US713B0586, US713B0587, US713B0588, US713B0589, US713B0590, US713B0592, US713B0593, US713B0594, US713B0595, US813B0015, US813B0016, US813B0032, US813B0037, US813B0038, US813B0039, US813B0121, US813B0151, US813B0152, US813B0153, US813B0154, US813B0155, US813B0156, US813B0157, US813B0158, US813B0159, US813B0160, US813B0161, US813B0162, US813B0163, US813B0164, US813B0183, US813B0184, US813B0185, US813B0186, US813B0187, US813B0188, US813B0189, US813B0190, US813B0191, US813B0192, US813B0193, US813B0194, US813B0195, US813B0196, US813B0232, US813B0396, US813B0397, US813B0398, US813B0399, US813B0400, US813B0401, US813B0402, US813B0403, US813B0404, US813B0405, US813B0406, US813B0407, US813B0408, US813B0409, US813B0410, US813B0411, US813B0468, US813B0469, US813B0470, US813B0471, US813B0472, US813B0473, US813B0474, US813B0475, US813B0476, US813B0477, US813B0478, US813B0479, US813B0480, US913B0026, US913B0027, US913B0028, US913B0029, US913B0030, US913B0031, US913B0032, US913B0041, US913B0051, US913B0059, US913B0085, US913B0086, US913B0101, US913B0102, US913B0103, US913B0104, US913B0105, US913B0130, US913B0132, US913B0133, US913B0134, US913B0135, US913B0137, US913B0138, US913B0139, US913B0140, US913B0141, US913B0142, US913B0143, US913B0177, US913B0178, US913B0179, US913B0185, US913B0202, US913B0216, US913B0217, US913B0218, US913B0219, US913B0220, US913B0221, US913B0222, US913B0223, US913B0232, US913B0252, US913B0253, US913B0254, US913B0255, US913B0259, US913B0260, US913B0299, US913B0300, US913B0301, US913B0302, US913B0303, US913B0316, US913B0317, US913B0318, US913B0319, US913B0332, US913B0333, US913B0336, US913B0337, US913B0338, US913B0339, US913B0340, US913B0349, US913B0359, US913B0360, US913B0385, US913B0408, US913B0458, US913B0459, US913B0486, US913B0487, US913B0488, US913B0489, US913B0490, US913B0499, US913B0504, US913B0505, US913B0506, US913B0565, US913B0566, US913B0567, US913B0568, USO13B0040, and USO13B0041.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips Medical Systems North America Inc.
- Reason for Recall:
- A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International System Date Format may result in calculation errors in Gestational Age Gestational Age (GA) and Established Due Date (EDD).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
Product Codes/Lot Numbers:
TRACE ITEM SERIAL NUMBERS in the UNITED STATES: US713B0171, US713B0207, US813B0017, US813B0018, US813B0019, US813B0020, US813B0022, US813B0023, US813B0024, US813B0025, US813B0122, US813B0123, US813B0125, US813B0127, US813B0128, US813B0129, US813B0131, US813B0132, US813B0134, US813B0135, US813B0233, US813B0234, US813B0235, US813B0236, US813B0237, US813B0238, US813B0239, US813B0240, US813B0423, US813B0424, US813B0425, US813B0426, US813B0427, US813B0428, US813B0429, US813B0430, US813B0431, US813B0432, US813B0433, US813B0434, US913B0033, US913B0034, US913B0035, US913B0036, US913B0037, US913B0038, US913B0039, US913B0040, US913B0057, US913B0060, US913B0061, US913B0062, US913B0063, US913B0064, US913B0065, US913B0066, US913B0106, US913B0107, US913B0108, US913B0109, US913B0110, US913B0111, US913B0112, US913B0113, US913B0144, US913B0176, US913B0201, US913B0256, US913B0257, US913B0350, US913B0363, US913B0364, US913B0365, US913B0366, US913B0367, US913B0368, US913B0369, US913B0380, US913B0384, US913B0395, US913B0396, US913B0397, US913B0398, US913B0399, US913B0400, US913B0401, US913B0402, US913B0409, US913B0441, US913B0444, US913B0445, US913B0446, US913B0447, US913B0503, US913B0522, US913B0614, US913B0615, US913B0616, US913B0618, US913B0619, and USO13B0043. TRACE ITEM SERIAL NUMBERS INTERNATIONAL: US513B0224, US513B0295, US513B0387, US513B0560, US613B0299, US713B0085, US713B0086, US713B0118, US713B0119, US713B0120, US713B0122, US713B0123, US713B0126, US713B0149, US713B0171, US713B0172, US713B0192, US713B0193, US713B0194, US713B0195, US713B0204, US713B0205, US713B0206, US713B0208, US713B0324, US713B0325, US713B0358, US713B0359, US713B0437, US713B0439, US713B0440, US713B0532, US713B0537, US713B0573, US713B0574, US713B0575, US713B0576, US713B0577, US713B0578, US713B0579, US713B0580, US713B0581, US713B0582, US713B0583, US713B0584, US713B0586, US713B0587, US713B0588, US713B0589, US713B0590, US713B0592, US713B0593, US713B0594, US713B0595, US813B0015, US813B0016, US813B0032, US813B0037, US813B0038, US813B0039, US813B0121, US813B0151, US813B0152, US813B0153, US813B0154, US813B0155, US813B0156, US813B0157, US813B0158, US813B0159, US813B0160, US813B0161, US813B0162, US813B0163, US813B0164, US813B0183, US813B0184, US813B0185, US813B0186, US813B0187, US813B0188, US813B0189, US813B0190, US813B0191, US813B0192, US813B0193, US813B0194, US813B0195, US813B0196, US813B0232, US813B0396, US813B0397, US813B0398, US813B0399, US813B0400, US813B0401, US813B0402, US813B0403, US813B0404, US813B0405, US813B0406, US813B0407, US813B0408, US813B0409, US813B0410, US813B0411, US813B0468, US813B0469, US813B0470, US813B0471, US813B0472, US813B0473, US813B0474, US813B0475, US813B0476, US813B0477, US813B0478, US813B0479, US813B0480, US913B0026, US913B0027, US913B0028, US913B0029, US913B0030, US913B0031, US913B0032, US913B0041, US913B0051, US913B0059, US913B0085, US913B0086, US913B0101, US913B0102, US913B0103, US913B0104, US913B0105, US913B0130, US913B0132, US913B0133, US913B0134, US913B0135, US913B0137, US913B0138, US913B0139, US913B0140, US913B0141, US913B0142, US913B0143, US913B0177, US913B0178, US913B0179, US913B0185, US913B0202, US913B0216, US913B0217, US913B0218, US913B0219, US913B0220, US913B0221, US913B0222, US913B0223, US913B0232, US913B0252, US913B0253, US913B0254, US913B0255, US913B0259, US913B0260, US913B0299, US913B0300, US913B0301, US913B0302, US913B0303, US913B0316, US913B0317, US913B0318, US913B0319, US913B0332, US913B0333, US913B0336, US913B0337, US913B0338, US913B0339, US913B0340, US913B0349, US913B0359, US913B0360, US913B0385, US913B0408, US913B0458, US913B0459, US913B0486, US913B0487, US913B0488, US913B0489, US913B0490, US913B0499, US913B0504, US913B0505, US913B0506, US913B0565, US913B0566, US913B0567, US913B0568, USO13B0040, and USO13B0041.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0368-2014
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A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated by