Recall Z-2484-2021
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
Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119
Codes / lots: Afiniti Diagnostic Ultrasound Systems: Affiniti 30 Model Number: 795121 Serial Numbers/UDI Codes US219E1452 (01)00884838074187(21)US219E1452 US220E0262 (01)00884838074187(21)US220E0262 US320E1098 (01)00884838074187(21)US320E1098 US320E1099 (01)00884838074187(21)US320E1099 US918E0145 (01)00884838074187(21)US918E0145 USN18E0607 (01)00884838074187(21)USN18E0607 USN18E1617 (01)00884838074187(21)USN18E1617 USN19E2219 (01)00884838074187(21)USN19E2219 USN19E2220 (01)00884838074187(21)USN19E2220 USN19E2221 (01)00884838074187(21)USN19E2221 Affiniti 30 Model Number: 795218 Serial Numbers/UDI Codes PU220E1330 N/A PU220E1331 N/A PU220E1332 N/A PU220E1333 N/A PU220E1334 N/A PU220E1335 N/A PU420E0442 N/A PU420E0658 N/A PU420E0659 N/A PU420E0660 (01)00884838097957 PU420E0761 (01)00884838074187 PU520E0703 (01)00884838074187 PU520E0713 N/A PU520E0854 (01)00884838074187 PU520E0855 N/A PU520E0856 N/A PU520E0857 N/A PU520E0858 N/A PU520E0859 N/A PU520E0861 N/A PU520E0965 N/A PU520E0966 N/A PU520E0967 N/A PU520E0968 N/A PU520E1012 N/A PU520E1013 (01)00884838074187 PU520E1014 (01)00884838074187 PU520E1015 N/A PU520E1016 N/A PU520E1017 (01)00884838074187 PU520E2820 (01)00884838097957 PU520E2821…
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-2484-2021
- 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-2483-2021 Class II | EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ…Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while… | 08/06/2021Completed |