| Class 2 Device Recall S83t Micro TEE Transducer | |
Date Initiated by Firm | March 27, 2011 |
Date Posted | April 25, 2011 |
Recall Status1 |
Terminated 3 on February 14, 2012 |
Recall Number | Z-2062-2011 |
Recall Event ID |
58320 |
510(K)Number | K030455 |
Product Classification |
Transducer, ultrasonic, diagnostic - Product Code IYN
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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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands
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For Additional Information Contact | Philips Customer Service 800-722-9377 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = IYN
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