ClearanceBrief
Recall Z-1757-2024 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

Philips Ultrasound, Inc.

5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Premium Carts that come with multiport adapters.

DateMay 3, 2024 (initiated Mar 23, 2024)
StatusOpen, Classified
ReasonUltrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in temperature above limit and patient burns
Root causeComponent change control
ActionOn 3/23/24, correction notices were distributed to customers who were advised of the following two ways to avoid the condition: Option 1: To prevent the issue from occurring, when using the TEE transducers, connect directly to the Compact 5000 system using the port on the side of the system as shown in Figure 3 below. The issue is associated with the MPA, therefore by using the port on the Compact 5000 directly, the issue is avoided. Option 2: Whenever adding a transducer to, or removing a transducer from the MPA, disconnect and reconnect the MPA connector on the Compact 5000 system connect
Quantity363
DistributionWorldwide - US Nationwide distribution including in the states of CA, CO, CT, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, NC, NH, NM, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA and the countries of Australia, Austria, Bahrain, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germ
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ul
Philips Ultrasound, LLC, Sep 27, 2022