Philips eL18-4 Transducer Probe Labeling Clarification on Useful Life Definition
Philips Ultrasound recalls 171,322 eL18-4 Transducer Probes to clarify labeling regarding the transducers' useful life. The FDA Class III recall is intended to ensure proper use within the transducers' functional parameters.
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 recall for a labeling clarification issue with no reported injuries, illnesses, or adverse events. The recall addresses documentation to define useful life parameters, which falls under documentation and labeling issues.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 eL18-4 Transducer Probes used in ultrasound systems nationwide. The FDA has classified this as a Class III recall.
The recall addresses labeling clarification to better define and communicate the useful life of the ultrasound transducers in clinical use. This clarification is intended to ensure that transducers are used only within their functional lifespan.
The affected transducers were distributed nationwide in the United States. Healthcare facilities and providers using these devices are included in the recall scope.
Healthcare providers and facilities using eL18-4 Transducer Probes should review the updated labeling information provided by Philips Ultrasound to understand the transducers' useful life parameters and ensure compliance with the manufacturer's guidance.
The recalled product
- Product
- eL18-4 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- labeling-deficiency
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. 989605431531
- 989605456291
- 989605391092
- 989605412062
- 989605409562
- UDI: (01)00884838070806(21)B3DVRN
- (01)00884838070806(21)B3NTCY
- (01)00884838070806(21)F05K3C
- (01)00884838070813(21)B3J1RW
- (01)00884838070813(21)B3KZY9
- (01)00884838070813(21)F04T5F
- (01)00884838070813(21)F0952L
- (01)00884838070813(21)F0DYQG
- (01)00884838070813(21)F0KLBR
- 010088483807080621F01T01
- (01)00884838070813(21)F0LWXK
- (01)00884838070813(21)F0GMZ9
- (01)00884838070806(21)F0JYQZ
- (01)00884838070813(21)F0GN24
- 010088483807081321F0FT37
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03
- HighPhilips Allura Imaging Systems Hard Drive Degradation Affects Functionality
FDA (Devices) · 2026-06-03
- ModerateMedtronic Deep Brain Stimulation Pocket Adaptor Kits recalled for incorrect expiration dates
FDA (Devices) · 2026-06-03
- SevereMedline spinal injection kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03