Reported May 15, 2024 · Ongoing
5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and…
Philips Ultrasound, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Ultrasound, Inc. · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- 5000 Compact Series Ultrasound Systems
- Product/REF
5500 CV/7951415500 P/7951435500 W/7951445500 G/795145
- and Product/REF5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Premium Carts that come with multiport adapters
- Lot codes and dates
- All Compact 5000 series systems manufactured on or before 20-Dec-2023 and purchased with Deluxe and Premium Cart options
- REF/UDI-DI/Serial Numbers
361 of 361 codes
505500 CV/795141/00884838116566/USN23P0684USN23P0623USN23P0624USN23P0685USN23P0720USN23P0615USN23P0627USN23P0611USN23P0683USN23P0682USN23P0625USN23P0173USN23P0164US823P0231USN23P0613USN23P0172USN23P0721USN23P0410USN23P0612USN23P0614USN23P0171US623P0141US823P0233US423P0844US523P1060US523P1061US523P1750US523P2536US523P2537US523P2672US523P2673US423P0842US623P0140US423P0759US623P0142US623P0230US623P0485US623P0486US623P0740US623P0790US623P0791US623P0792US623P0866US623P0867US423P0843US623P0966US423P0672US423P0673US423P0674US423P0712US423P0757US823P0132US823P0232US823P0318US823P0319US823P0320US823P0321US823P0322US823P0507US823P0508
- Amount recalled
- 363
Where it was sold
Why it was recalled
Ultrasound 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
This product could cause temporary or reversible health problems — stop using it.
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