Events

Device Recall S83t Micro TEE Transducer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems Nederlands 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    58320
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2062-2011
  • 사례 시작날짜
    2011-03-27
  • 사례 출판 날짜
    2011-04-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98980
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Transducer, ultrasonic, diagnostic - Product Code IYN
  • 원인
    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.
  • 조치
    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.

Device

Device Recall S83t Micro TEE Transducer
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • Manufacturer
    Philips Medical Systems Nederlands

Manufacturer

Philips Medical Systems Nederlands
  • 제조사 주소
    Philips Medical Systems Nederlands, Veenpluis 4-6, Best Netherlands
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA