Recall Z-2483-2021
Philips Ultrasound Inc · initiated August 6, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231
Codes / lots: EPIQ Diagnostic Ultrasound Systems: EPIQ 5 Model Number: 795120 Serial Numbers/UDI Codes US118C0391/ (01)00884838047686(21)US118C0391; US118C1388/ (01)00884838047686(21)US118C1388; US118C1389/ (01)00884838047686(21)US118C1389; US119C0516/ (01)00884838047686(21)US119C0516; US119C0517/ (01)00884838047686(21)US119C0517; US119C0644/ (01)00884838047686(21)US119C0644; US121C0839/ (01)00884838047686(21)US121C0839; US219C0823/ (01)00884838047686(21)US219C0823; US219C0949/ (01)00884838047686(21)US219C0949; US319C0210/ (01)00884838047686(21)US319C0210; US518C1519/ (01)00884838047686(21)US518C1519; US518C1528/ (01)00884838047686(21)US518C1528; US719C0285/ (01)00884838047686(21)US719C0285; US719C0603/ (01)00884838047686(21)US719C0603; US918C0543/ (01)00884838047686(21)US918C0543; US918C1811/ (01)00884838047686(21)US918C1811; USD18C1243/ (01)00884838047686(21)USD18C1243; EPIQ 5C Model Number: 795205 Serial Numbers/UDI Codes US114C0239/ N/A; US114C0240/ N/A; US114C0241/ N/A; US114C0271/ N/A; US114C0272/ N/A; US114C0286/ N/A; US114C0287/ N/A; US114C0308/ N/A; US114C0366/ N/A; US117C0337/ (01)00884838047686(21)US117C0337; US215C0536/ N/A; US315C0582/ N/A; US316C0339/ N/A; US414C0158/ N/A…
Reason for recall
Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
FDA-determined cause: Software design
Action taken
On 08/06/2021, the firm sent via certified mail an "URGENT Medical Device Correction" Notification Letter to customer informing them that due to a software defect, when reviewing or adjusting xPlane exam results, there is a potential for the ultrasound systems to become unresponsive (Lock-up) preventing users from continuing clinical use. The ultrasound system provides an error notification including method to restart and bring system back to normal use. The Recalling Firm has received a report of an ultrasound system locking up multiple times during an open cardiac procedure while using a Transesophageal Echocardiogram (TEE) transducer. Each lock-up required at least one system reboot to regain functionality. Customers are instructed to: 1) Determine the software version on their ultrasound system by: - Power up the system and allow it to complete the boot sequence; - Press Support on the right side of the control panel; - Under System Management, click System Information; - The software version is listed in the Software Information Section. 2) Circulate this notice to all users of this device so that they are aware of the product issue and associated hazard/harm. 3) Post this notice near the affected unit(s) for ease of reference. 4) Complete and return the response form to the Recalling Firm promptly and no later than 30 days from receipt via email to: ultrasound.corrections@philips.com or fax to 1-833-512-7756. In addition, because the software defect may intermittently cause the system to lock-up when exiting Review mode, customer are asked to take the following steps to minimize the likelihood of occurrence: 1. Acquire a loop while in xPlane, xPlane Doppler, or Dual mode. 2. Do NOT adjust an imaging control (for example: Rotate, Tilt, Gain) while the loop capture is in progress.* (*If the imaging controls have been adjusted during the loop capture, Philips recommends that the system be rebooted prior to reviewing the loop in Review mode). 3. Allow the loop
Details
- Recall number
- Z-2483-2021
- Initiated
- August 6, 2021
- Product code
- IYO – System, Imaging, Pulsed Echo, Ultrasonic
- Quantity
- Total = 10,583 systems (EPIQ and Afiniti)
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Albania, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus…
- Recalling firm
- Philips Ultrasound Inc, Bothell, WA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2484-2021 Class II | Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models:…Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while… | 08/06/2021Completed |