Recall Z-2517-2023— Philips Ultrasound, Inc.
Class II · Completed
Class II FDA medical device recall by Philips Ultrasound, Inc., initiated 2023-06-30. It names 6 FDA 510(k) clearances: K222648, K132304, K120321 and 3 more. Product: 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000. Reason: 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..
- Recalling firm
- Philips Ultrasound, Inc.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2023-06-30
- Firm location
- Bothell, WA, United States
510(k) clearances named in this recall
6 on FDA's record- K222648 — 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)
- K132304 — EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
- K120321 — CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM
- K081661 — HD15 DIAGNOSTIC ULTRASOUND SYSTEM
- K043535 — HD11 DIAGNOSTIC ULTRASOUND SYSTEM
- K042540 — PHILIPS IU22 ULTRASOUND SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.