Events

Device Recall Pentacam AXL 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Oculus Optikgeraete GMBH 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
    78606
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0635-2018
  • 사례 시작날짜
    2017-11-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-03-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159872
  • 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
    Device,analysis,anterior segment - Product Code MXK
  • 원인
    The device software versions have an anomaly which may produce an erroneous marking for the quality specification value.
  • 조치
    Oculus issued an email on November 21, 2017 to their U.S. subsidiary which contained a Mandatory Software Update notification. The email informed the U.S. subsidiary that a mandatory software update was planned for the Pentacam AXL in possession of their customers, provided the software versions affected, and the reason for the mandatory update. The email explained the USB thumb drive will be shipped to the U.S. subsidiary for each serial number that may be affected. The U.S. subsidiary was to match the serial numbers to their customers and complete the attached customer letter for issuance to each of the customers. The U.S. subsidiary is then supposed to issue the letter and the USB thumb drive via certified mail to each of their customers who have the affected serial numbers. The customer is to send back the completed, signed form verifying the mandatory software update has been installed on all working places on which the Pentacam AXL software is running or that the procedure was performed by an authorized distributor. For further questions, please call (425) 670-9977

Device

Device Recall Pentacam AXL
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers:  70100 0021 6190, 70100 0301 5170, 70100 0311 6150, 70100 0331 7130, 70100 0401 5101, 70100 0421 6101, 70100 0641 7170, 70100 0831 7150, 70100 1021 6190, 70100 1101 5170, 70100 1541 7170, 70100 1631 7140, 70100 1731 7140, 70100 1831 7150, 70100 1901 6130, 70100 2211 6150, 70100 2221 6190, 70100 2231 7130, 70100 2241 7160, 70100 2511 6170, 70100 2641 7170, 70100 2731 7140, 70100 2801 6130, 70100 2821 7110, 70100 2931 7150, 70100 3221 6190, 70100 3701 6110, 70100 3731 7140, 70100 3931 7150, 70100 4041 7160, 70100 4211 6150, 70100 4231 7130, 70100 4401 5121, 70100 4511 6170, 70100 4711 6170, 70100 4831 7150, 70100 4931 7150, 70100 5311 6160, 70100 5531 7140, 70100 5611 6170, 70100 5621 6111, 70100 5831 7150, 70100 5931 7150, 70100 6101 5170, 70100 6221 6101, 70100 6231 7130, 70100 6331 7130, 70100 6401 5121, 70100 6421 6101, 70100 6631 7140, 70100 6801 6130, 70100 6811 6190, 70100 6821 7110, 70100 7041 7160, 70100 7221 6101, 70100 7401 5121, 70100 7511 6170, 70100 7531 7140, 70100 7631 7140, 70100 7731 7150, 70100 7831 7150, 70100 7931 7150, 70100 8121 6190, 70100 8141 7160, 70100 8511 6170, 70100 8531 7140, 70100 8611 6170, 70100 8631 7140, 70100 8721 7110, 70100 8731 7150, 70100 9041 7160, 70100 9221 6101, 70100 9231 7130, 70100 9301 5101, 70100 9411 6160, 70100 9521 6111, 70100 9711 6190, 70100 9731 7150, 70100 9911 6190, 70100 9931 7150, 70100 7411 6160, 70100 8021 6190, and 70100 4531 7140.
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : CA and FL. There were no foreign/military/government accounts.
  • 제품 설명
    OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. || The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, and lens of the eye, to evaluate corneal shape, analyze condition of the lens (opaque crystalline lens), analyze the anterior chamber angle, analyze anterior chamber depth, analyze the volume of the anterior chamber, analyze anterior or posterior cortical opacity, analyze the location of cataracts (nuclear, sub capsular and/or cortical), using cross slit imaging with densitometry, corneal thickness, axial length, and white-to-white distance. The Pentacam AXL also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.
  • Manufacturer
    Oculus Optikgeraete GMBH

Manufacturer

Oculus Optikgeraete GMBH
  • 제조사 주소
    Oculus Optikgeraete GMBH, Munchholzhauser Str. 29, Wetzlar Germany
  • Source
    USFDA