Philips 3D9-3v Ultrasound Transducers Recalled for Refurbishment Beyond Useful Life
Philips recalls 3D9-3v ultrasound transducers that were refurbished beyond their useful life, risking unreliable device performance. About 5,230 units were distributed nationwide and to 50+ countries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for ultrasound transducers refurbished beyond their useful life. The hazard is potential unreliable device performance affecting diagnostic reliability; no injuries or hospitalizations have been reported.
Plain-English summary
Philips Ultrasound, Inc. is recalling its 3D9-3v transducer devices that were refurbished beyond their useful life. Approximately 5,230 units were distributed domestically and internationally across more than 50 countries.
Devices refurbished beyond their intended useful life may not function reliably or maintain expected performance. The recall affects healthcare facilities and providers using these transducers.
Affected devices can be identified by model numbers 989605395622, 989605415032, 989605440832, 989605440831, and 989605325181, along with specific UDI and serial numbers listed in the FDA recall notice. Customers should contact Philips Ultrasound, Inc. for instructions regarding device verification, repair, replacement, or return.
The recalled product
- Product
- Philips 3D9-3v Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-malfunction
- degraded-performance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. 989605395622
- 989605415032
- 989605440832
- 989605440831
- 989605395622
- 989605325181
- UDI: (01)00884838061545(21)B0D9FJ
- (01)00884838061545(21)B10HWZ
- (01)00884838061545(21)B1CQY1
- (01)00884838061453(21)B13DR6
- (01)00884838061545(21)B1C54Z
- (01)00884838061545(21)B1MKLW
- (01)00884838061545(21)B1MQGQ
- (01)00884838061545(21)B1KWYY
- (01)00884838061545(21)B1712M
- (01)00884838061545(21)B1M9ZT
- (01)00884838061545(21)B1DTRL
- (01)00884838061545(21)B1K7BL
- (01)00884838061545(21)B1RY9G
- (01)00884838061453(21)B0T4K5
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03