Philips recalls S8-3t transducers for potential patient injury due to incorrect temperature measurement during transesophageal echocardiography (TEE) scans.
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 some S8-3t transducers used with their ultrasound systems because they may not properly measure temperature during use. This could cause the transducer to overheat and injure patients during TEE scans.
The transducers were not properly programmed during manufacturing, causing the system to fail in measuring the distal tip temperature. Without accurate temperature readings, the transducer may not activate auto-cool, potentially overheating and causing patient injury.
Medical professionals using Philips ultrasound systems for transesophageal echocardiography (TEE) may be affected. Patients undergoing TEE scans with these transducers are at risk of injury.
Check for the UDI (01)00884838073524 or REF 989605431171 on the transducer. These transducers work with Philips EPIQ 7, Affiniti 70, EPIQ 5, and EPIQ CVxi ultrasound systems.
Look for the UDI (01)00884838073524 or REF 989605431171 on the transducer.
Philips discovered that some S8-3t transducers were not properly programmed during manufacturing, which can cause the system to fail in measuring temperature during use. This may lead to patient injury.
The transducer may not initiate auto-cool during use, potentially overheating and causing patient injury during transesophageal echocardiography (TEE) scans.
Check for the UDI (01)00884838073524 or REF 989605431171 on the transducer. These transducers are used with Philips EPIQ 7, Affiniti 70, EPIQ 5, and EPIQ CVxi ultrasound systems.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-1843-2020 — Philips Philips Hello, I own a Philips that is covered by recall Z-1843-2020 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.