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

Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.

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: [email protected] 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