Philips Ultrasound recalled 75 OMNI III TEE Ultrasound Transducers distributed nationwide in the United States. The recall concerns labeling to define the useful life of these transducers in the field. Healthcare facilities should stop using the devices immediately and follow the recall instructions from Philips Ultrasound, Inc.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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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The Philips OMNI III TEE Ultrasound Transducer is used in intraprocedural imaging to guide trans esophageal echocardiography. Hospitals and clinics purchase these transducers to perform detailed cardiac assessments during procedures.
The recall addresses labeling and documentation to define the useful life of the transducers in the field. Using a transducer beyond its labeled life could compromise performance guidance or maintenance workflows.
This recall is not described as part of a broader industry pattern in the provided data.
Facilities must halt use immediately to align with labeling guidance. There is cost and scheduling impact for device replacement and compliance paperwork.
Recall letter and enforcement notice from the FDA listing the model numbers and UDIs. Original recall URL: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number
Refunds or replacements are typically processed within 4-8 weeks after confirmation of eligibility.
Keep a copy of the recall notice, model numbers, UDI data, and all correspondence. Photograph affected units and record serials for records.
Quantity: 75 units. Distribution: US Nationwide distribution. Sold at: Unknown. Sold from: Unknown. Price: Unknown. Models include: Model No. 989605440701, 989605440702, 989605440772, 989803001561 and multiple UDI variants listed in the recall notice.
No injuries or incidents have been reported.
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