S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471. The User information is labeled in p

FDA device recall Z-2062-2011 · posted 2011-04-25 · Terminated

Recall details

Recalling firm

Philips Medical Systems Nederlands

Reason for recall

Users of the Philips model S8-3t Micro TEE Transducer have reported that significant image quality degradation may occur after a number of use/cleaning cycles. If users do not inspect the transducer for such damage prior to each use, imaging may not always be available, which could pose a risk for patients.

Action taken

Philips Healthcare began mailing Urgent Medical Device Correction letter on March 28, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers are being instructed on how to inspect the distal tip for defects that cause image quality degradation, and to plan for epicardial / transthoracic ultrasound imaging as an adjunct to the S8-3t. Customers are also reminded to carefully follow cleaning described under Handling the S8-3t Transducer, of Philips' iE33 System User Information. Customers can call Philips Customer Service at 800-722-9377 and reference to FCO 79500198 for any questions about this recall.

Root cause

Other

Status

Terminated

Product code

IYN

Quantity affected

155 units

Distribution

Worldwide Distribution - USA AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, KY, LA, MA, MD, MI, MN, MS, NC, ND, NH, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of Austra

Date initiated

2011-03-27

Date posted

2011-04-25

Date terminated

2012-02-14

Location

Best, Netherlands

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