Philips X7-2t Ultrasound Transducers Recalled for Refurbishment Beyond Useful Life
Philips is recalling 5,230 X7-2t ultrasound transducers that were refurbished beyond their useful life. Improperly refurbished devices may not perform as intended for diagnostic applications.
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 recall with no reported illnesses or injuries. The hazard involves ultrasound transducers refurbished beyond their useful life, creating potential risk of degraded device performance and diagnostic accuracy without reported harm.
Plain-English summary
Philips Ultrasound, Inc. is recalling approximately 5,230 X7-2t ultrasound transducer devices. These devices were refurbished beyond their useful life, exceeding their intended service parameters.
Ultrasound transducers that are refurbished beyond their designed useful life may not perform as intended, potentially affecting device function and diagnostic accuracy. The devices may experience performance degradation or malfunction during clinical use.
The recalled transducers were distributed domestically throughout the United States and internationally to more than 50 countries including Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, France, Germany, Hong Kong, India, Japan, Mexico, Netherlands, Poland, Spain, Sweden, Taiwan, Thailand, United Kingdom, and others.
Healthcare facilities and users should contact Philips Ultrasound, Inc. for information regarding affected devices and appropriate actions related to device status and continued safe use.
The recalled product
- Product
- Philips X7-2t Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Category
- Medical Device — Ultrasound
- Hazard
- refurbishment-defect
- device-malfunction
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. 989605350454
- 989605361911
- 989605414122
- 989605461941
- 989605350452
- 989605350451
- 989605455171
- 989605350453
- 989605438611
- UDI: Unique Device Identifier (UDI)
- (01)00884838061668(21)B144RL
- (01)00884838061668(21)B28L3F
- (01)00884838061668(21)B26MZ9
- (01)00884838061668(21)B3DT21
- (01)00884838061668(21)B3DP0K
- (01)00884838061668(21)B2JJFV
- (01)00884838061668(21)B0T9J4
- (01)00884838061668(21)B2XCH6
- (01)00884838061668(21)B3DRBG
- (01)00884838061668(21)B21DC0
Distribution
Distributed nationwide across the United States.
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