Reported Sep 13, 2023 · Completed
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15;…
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?
- 3D9-3v Transducer
- accessory to Philips Ultrasound Systems
EPIQ EliteAffiniti 3050and 70ClearVue 850HD15iU22and Compact 5000
- Lot codes and dates
- UDI-DI00884838061545
- Serial Numbers
449 of 449 codes
F07VBZF083JPF086Z5F088QCF08JPFF08K4HF08VLPF08VLYF08W1CF08W1DF08W1JF08W1KF08W1LF08W1MF08W1QF08WXPF08WXYF08WZYF08X01F08X02F08X03F08X04F08Y2TF08ZR3F08ZR4F08ZR5F092BQF092BRF092BVF097QQF097QVF097QWF09BTBF09BTCF09BTDF09BTGF09BTHF09BTNF09BTPF09C1GF09C1HF09C1LF09C1MF09F3RF09F3TF09F3VF09F3XF09F3YF09F3ZF09F40F09F41F09F42F09F43F09F45F09F48F09F49F09F4CF09F4DF09F4FF09F4G
- Amount recalled
- 449
Where it was sold
Why it was recalled
Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail.
This product could cause temporary or reversible health problems — stop using it.
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