Philips recalls some S8-3t transducers for potential temperature measurement failure during transesophageal echocardiography (TEE) that could cause patient injury.
The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the transducer. This issue may result in affected transducers not initiating auto-cool during use which could result in patient injury
Philips is recalling certain S8-3t transducers used with their iE33 ultrasound system. These transducers may not properly cool during use, risking patient injury during transesophageal echocardiography (TEE) procedures.
The transducers may not initiate auto-cool during use because they weren't properly programmed. This could cause overheating at the transducer tip, potentially injuring the patient during TEE procedures.
Healthcare providers using the transducers for TEE procedures are most at risk. Patients undergoing TEE with these transducers could face injury.
Check for the UDI (01)00884838067523 or REF 989605420183 on the transducer. These transducers are used with Philips iE33 ultrasound systems for TEE studies.
Look for the UDI (01)00884838067523 or REF 989605420183 on the transducer.
Philips discovered some S8-3t transducers weren't properly programmed during manufacturing, which may cause temperature measurement failure during use.
The transducer may not initiate auto-cool, potentially causing overheating at the tip and patient injury during TEE procedures.
Check for the UDI (01)00884838067523 or REF 989605420183 on the transducer, which is used with Philips iE33 ultrasound systems for TEE studies.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1844-2020 — Philips Philips Hello, I own a Philips that is covered by recall Z-1844-2020 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
