Transducer S7-3t recall
Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound…
Why was Transducer S7-3t recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots.
- Product
- Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound…
- Recalling firm
- Philips Ultrasound Inc
- Quantity
- N/A
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Recall date
- May 13, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)