Events

Device Recall Philips Ultrasound QLAB 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Ultrasound, Inc. 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
    68756
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2110-2014
  • 사례 시작날짜
    2014-07-09
  • 사례 출판 날짜
    2014-07-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-11-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128605
  • 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
    System, image processing, radiological - Product Code LLZ
  • 원인
    The qlab a2dq and acmq features have a defect that may use incorrect measurement values under specific conditions.
  • 조치
    Philips Medical Systems notified customers of the voluntary recall by sending a certified URGENT-Medical Device Correction letter, dated 2014 JUL 09, to all US and Canadian consignees. Philips representatives will distribute the letter internationally. Follow-up letters to wholesale customers will be provided and wholesalers are requested to forward copies of recall letters and response forms to their customers. Philips Medical Systems will also have Customer Reply Cards returned for tracking purposes. Customers are directed to call local Philips representative or Philips Customer Service at 1-866-767-7822.

Device

Device Recall Philips Ultrasound QLAB
  • 모델명 / 제조번호(시리얼번호)
    ****SYSTEM BASED ID IN THE US***********************  12DD-14B7BC8B-295F, 25EB-143A3021-2864, 3E1D-145FC2CB-28AF,  5914-14544E46-2898, 5936-13FD3F20-27EA, 91B6-1437E5A0-285F,  9C64-1478F656-28E1, A1DD-14426F8B-2874, AC8B-14838041-28F6,  C501-13FAF49F-27E5, CCFB-144184F1-2872, and J57B-147C2B71-28E8.   *****SYSTEM BASED ID OUTSIDE THE US************************  189A-13D31774-2796, 1B4E-13CD97D8-278B, 2B31-1486400F-28FC,  2B42-145AB87C-28A5, 2E29-13D2A227-2795, 3099-147B40D7-28E6,  3B7A-1439BAD4-2863, 4BD4-13C1AE06-2773, 4E88-13BC2E6A-2768,  50E7-149054AD-2910, 512B-13E23661-27B4, 539B-148AD511-2905,  564F-14855575-28FA, 5682-1402BEBC-27F5, 5E5A-14A05E34-2930,  5E6B-1474D6A1-28D9, 611F-146F5705-28CE, 66CB-13B63981-275C,  6BCD-14B067BB-2950, 6ED6-13D14240-2792, 73E9-149FE8E7-292F,  76F2-13C0C36C-2771, 7951-1494E9AF-2919, 7C05-148F6A13-290E,  7C16-1463E280-28B7, 7C49-13E14BC7-27B2, 7C5A-13B5C434-275B,  7EA8-14B5720A-295A, 8465-13D0CCF3-2791, 8C5F-14175D45-281E,  8F35-13BACE83-2765, 91E9-13B54EE7-275A, A46F-1493FF15-2917,  B74A-1499H964-2921, C4CE-147D8B58-28EA, D798-14AE1D3A-294B,  D7A9-148295A7-28F4, DA5D-147D160B-28E9, DFB4-149D9E66-292A,  DFC5-147216D3-28D3, E268-14981ECA-291F, E7BF-14B8A725-2960,  EA95-145C1863-28A7, ED7C-13D4H20E-2797, F598-13C3833A-2776,  FDA3-13DE8BF9-27AC, and XAF4-1445A4A6-287B.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of CA, IA, KY, MD, NY, PA, UT, VA, WA and WI. Also distributed in Australia, Belgium, Canada, India, Italy, Japan, South Korea, Netherlands, New Zealand, Spain, Sweden, and Switzerland.
  • 제품 설명
    QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
  • Manufacturer
    Philips Ultrasound, Inc.

Manufacturer

Philips Ultrasound, Inc.
  • 제조사 주소
    Philips Ultrasound, Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA