Philips Recal Size 40 L12-5 Ultrasound Transducers for Labeling Life Span Recall (2026)
Philips recalled 40 L12-5 ultrasound transducers distributed nationwide in the United States after regulators flagged labeling to define the devices' useful life. The recall concerns labeling clarity rather than a device malfunction. Healthcare providers and patients should stop using the device immediately and await instructions from Philips Ultrasound, Inc or their healthcare provider.
Quick Facts at a Glance
Recall Date
September 5, 2025
Hazard Level
HIGH
Brand
Philips Ultrasound
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL
Hazard Information
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips Ultrasound, Inc or your healthcare provider for instructions. Notification method: Letter
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Product Details
Quantity: 40 units. Distribution: US Nationwide. Models include 989605412401, 989605387311, 989605418552, 989605408173, 989605438481, 989605420231. UDI entries and serial numbers listed: UDI (01)00884838067851(21)B27H7T; (01)00884838067974(21)B0B0B1; (01)00884838067851(21)B16RRG; (01)00884838067974(21)B0HWBM; (01)00884838067974(21)B0B39M; (01)00884838067851(21)B1N2FG; (01)00884838067851(21)B1DD6B; (01)00884838067851(21)B27GVB; (01)00884838067851(21)B27RQ7; (01)00884838067851(21)B1WT18; (01)00884838067851(21)B1N1JB. Serial Nos. B107H4, B106RJ, B02RKJ.
The Hazard
The recall is to provide clarification and labeling to define the useful life of ultrasound transducers in the field. There is no described device malfunction in the notice.
Reported Incidents
No injuries or incidents have been reported.
What to Do
1. Stop using the product. 2. Follow the recall instructions provided by the manufacturer. 3. Contact Philips Ultrasound, Inc or your healthcare provider for instructions. 4. Notification method: Letter.
Contact Information
Recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1620-2026. For questions, contact Philips Ultrasound support via the recall notification and your healthcare provider.
Key Facts
40 units recalled
Model numbers include 989605412401, 989605387311, 989605418552, 989605408173, 989605438481, 98960542
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