Philips Ultrasound Transducers Recalled for Degraded Components Beyond Useful Life
Philips Ultrasound, Inc. is recalling approximately 5,230 Philips X5-1 transducer units that were refurbished beyond their useful life, which may compromise device performance and reliability.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported hospitalization, injuries, or illnesses. The devices were refurbished beyond their useful life, creating a durability and performance concern rather than an acute safety defect. This represents a precautionary recall of aging equipment.
Plain-English summary
Philips Ultrasound, Inc. is recalling 5,230 units of the Philips X5-1 Transducer, an ultrasound imaging device. The recalled transducers were refurbished beyond their useful life, which raises concerns about their structural integrity and performance reliability.
The affected devices were distributed nationwide throughout the United States and internationally to approximately 50 countries including Canada, Australia, the United Kingdom, Japan, and others. Affected units include those with Model No. 989605400802 and the specific serial numbers listed below.
Medical facilities and clinics should check their equipment inventory for the affected transducers using the provided serial numbers (B2XMDQ, B3H27D, B2ZXZB, B26JC4, B3GYXN, B2ZXD8, B1CGYC, B3GJB2, B2MQZ3, B3L198, B3KC2D, B3MTN1, B2894C, B1FHTZ) and contact Philips Ultrasound, Inc. for guidance on device replacement or remediation.
The recalled product
- Product
- Philips X5-1 Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- durability-defect
- device-degradation
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. 989605400802
- UDI: (01)00884838061422(21)B2XMDQ
- (01)00884838061422(21)B3H27D
- (01)00884838061422(21)B2ZXZB
- (01)00884838061422(21)B26JC4
- (01)00884838061422(21)B3GYXN
- (01)00884838061422(21)B2ZXD8
- (01)00884838061422(21)B3GJB2
- (01)00884838061422(21)B2MQZ3
- (01)00884838061422(21)B3L198
- (01)00884838061422(21)B3KC2D
- (01)00884838061422(21)B3MTN1
- (01)00884838061422(21)B2894C
- Serial No. B2XMDQ
- B3H27D
- B2ZXZB
- B26JC4
- B3GYXN
- B2ZXD8
- B1CGYC
Distribution
Distributed nationwide across the United States.
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