Philips S8-3 Ultrasound Transducer Probe labeling clarification on useful life
Philips is clarifying labeling on 171,322 S8-3 Transducer Probe units to better define the useful life of ultrasound transducers in clinical use.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III medical device involving labeling clarification regarding product useful life, with no reported patient harm, injuries, or specific safety defect.
Plain-English summary
Philips Ultrasound, Inc is recalling approximately 171,322 units of the S8-3 Transducer Probe to provide clarification and updated labeling regarding the useful life of these ultrasound transducers.
The labeling clarification is being issued to ensure that the useful life of the ultrasound transducers is properly defined for healthcare providers and clinical users in the field.
The S8-3 Transducer Probe is distributed nationwide. Affected units include multiple model numbers and production batches as documented in the recall.
Healthcare facilities and providers using this equipment should contact Philips for updated labeling information regarding the product's useful life to ensure appropriate clinical use.
The recalled product
- Product
- S8-3 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- insufficient-labeling
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. 989605361882
- 989605440752
- 989605361963
- 989605438401
- 989605387401
- 989605387421
- 989605400802
- 989605361961
- 989605361881
- 989605362004
- 989605362002
- 21750A
- 989605362003
- 989605440682
- UDI: (01)00884838067806(21)B2D78M
- (01)00884838067806(21)B2PXNB
- (01)00884838067806(21)B2TFQK
- (01)00884838067806(21)B2TFQL
- (01)00884838067806(21)B2TGWJ
- (01)00884838067806(21)B2TGWP
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03