Philips Medical Systems Nederlands: S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471. The User information is labeled in part: "***iE33 Ultrasound System ***User Information Update***4535 614 04811 Rev A***New S8-3t TEE Transducer*** This release of the iE33 Ultrasound System supports the S8-3t transesophageal echocardiographic (TEE) transducer***Manufactured by Philips Ultrasound***22100 Bothell-Everett Highway***Bothell, WA 98021-8431***USA***Telephone: +1 425-487-7000 or 800-426-2670***Fax: +1 425-485-6080***www.philips.com/ultrasound***". The S8-3t transducer is indicated for adult cardiac, pediatric cardiac and transesophageal uses, and operates in the following modes: B, M, Color M, CWD, PWD, high PRF, color Doppler, harmonic, XRES. The S8-3t Micro TEE is indicated for use on patients weighing at least 2.5 kg undergoing echocardiography exams in the ICU, echocardiography lab, interventional suite, or in the operating room during cardiac surgery. The S8-3t Micro TEE transducer can be identified by the designation "S8-3t" printed on the connector housing of the transducer.

Recall number

Z-2062-2011

Recalling firm

Philips Medical Systems Nederlands

Product

S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471. The User information is labeled in part: "***iE33 Ultrasound System ***User Information Update***4535 614 04811 Rev A***New S8-3t TEE Transducer*** This release of the iE33 Ultrasound System supports the S8-3t transesophageal echocardiographic (TEE) transducer***Manufactured by Philips Ultrasound***22100 Bothell-Everett Highway***Bothell, WA 98021-8431***USA***Telephone: +1 425-487-7000 or 800-426-2670***Fax: +1 425-485-6080***www.philips.com/ultrasound***". The S8-3t transducer is indicated for adult cardiac, pediatric cardiac and transesophageal uses, and operates in the following modes: B, M, Color M, CWD, PWD, high PRF, color Doppler, harmonic, XRES. The S8-3t Micro TEE is indicated for use on patients weighing at least 2.5 kg undergoing echocardiography exams in the ICU, echocardiography lab, interventional suite, or in the operating room during cardiac surgery. The S8-3t Micro TEE transducer can be identified by the designation "S8-3t" printed on the connector housing of the transducer.

Status

Terminated

Initiated

2011-03-27

Posted

2011-04-25

Terminated

2012-02-14

Reason

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.

Root cause

Other

Action

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.

Quantity

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 Australia, Austria, Belgium, Chile, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Korea Rep, Netherlands, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Ukraine, and United Kingdom.

Lot, serial or model codes

System Code Serial Numbers:  02KHRT, 02L66Z, 02LJ0G, 02LJKW, 02R6K9, 02R8HK, 02R8JJ, 02RB69, 02RBRM, 02RBVK, 02RDQJ, 02RDTX, 02RPDG, 02RPT9, 02X3KY, 02X3RG, 02X3WD, 02X3WD, 02X434, 02X43J, 02X43Y, 02X4JH, 02XDNH, 02XF24, 02XF6J, 02XJXG, 02XK9H, 02XKBF, 02XKCH, 02XKCQ, 02XKCQ, 02XKCY, 02XL54, 02XRN8, 02XT0Z, 02XTHZ, 034JBN, 034K6R, 034KC0, 034L0J, 034L34, 034L4W, 034L5X, 034LDN, 034V9K, 034VL2, 034VMJ, 034VP2, 034VTC, 034VZ0, 034W05, 034W20, 0353HK, 039VGF, 039VPZ, 039VWY, 039VZL, 039W1G, 039W66, 039W86, 039W9X, 039WB4, 039WB8, 039WBY, 039WX8, 039WY1, 039WY2, 039X41, 039X49, 039X99, 039XC1, 039XHG, 039XHG, 03B48J, 03B49T, 03B4GG, 03B4H4, 03B4HC, 03B4JQ, 03B4QR, 03B4V6, 03B4ZX, 03B51R, 03B521, 03B524, 03B566, 03B57R, 03B597, 03B8QB, 03B8RR, 03B8TX, 03B8TZ, 03B8V3, 03B8X1, 03B8X6, 03B8ZY, 03B905, 03B906, 03B90L, 03B912, 03B92H, 03B92H, B008YN, B008YY, B00905, B00919, B009BW, B009FG, B009FY, B009JX, B009MY, B009VM, B009ZW, B009ZW, B00D88, B00DBN, B00DF1, B00DL4, B00DLC, B00DQG, B00DR7, B00DXP, B00DZX, B00F05, B00F11, B00F14, B00F20, B00F3C, B00F5M, B00F5V, B00F61, B00F7J, B00F89, B00HRV, B00J3X, B00J73, B00JCD, B00JG5, B00JK0, B00JKG, B00JMC, B00P7K, B00P7R, B00P9C, B00PB0, B00PDV, B00PFB, B00PGV, B00PKG, B00PM0, B00PMP, B00PPW, B00PQ5, B00PT5, and B00PW4.

510(k) numbers

["K030455"]

PMA numbers

not on file

Product code

IYN

Firm FEI

3002807880

Firm city

Best

Firm state

not on file

Firm country

Netherlands

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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