Philips Ultrasound Inc Recall: Philips EPIQ Diagnostic Ultrasound System; Model Numbers: E
Philips Ultrasound Inc Recall: Philips EPIQ Diagnostic Ultrasound System; Model Numbers: E is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Philips Ultrasound Inc; Product: Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx
| Recalling firm | Philips Ultrasound Inc |
|---|---|
| Product | Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only,100-240V~50/60 Hz, 600VA |
| Reason for recall | The manufacturer discovered an issue associated with the EPIQ Image Boost with xPlane and Color Flow or Doppler while using the X8-2t TEE Transducer. If Image Boost is enabled the color box shows flow visualization not accurately represent the fluid flow. Similarly, if Image Boost is enabled, both CW and PW Doppler traces will not accurately represent the fluid flow. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US - AL, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE,NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI and WV OUS- Austria, Australia, Belgium, Canada, Chezh Republic, Croatia, Denmark, Egypt, Finland, France, Hong Kong, Indonesia, India, Ireland, Ital |
| Recall initiated | 20201216 |
| Recall number | Z-0944-2021 |
| Category | device |
| State | WA |
| Country | United States |
$29/mo
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