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史赛克公司

争议事件

以下收录公开来源中与该品牌相关的争议事件。列出一条并不表示过错已经证实。

返回词条共 8 条

  1. 2019

    Stryker宣布对部分LIFEPAK 15设备采取自愿现场纠正措施

    整改

    Stryker宣布对部分LIFEPAK 15监护仪/除颤器采取自愿现场纠正措施。设备的Shock按钮可能因氧化而无法发出除颤电击;公司表示正联系客户安排纠正,包括更换受影响的键盘。该公告仅涉及相关设备,并将此行动描述为自愿性质。

    品牌回应

    • 整改 — Stryker

      The company is contacting customers with impacted devices to schedule the correction of their device(s), which will include replacement of the affected keypad.

    来源摘录

    • The company is notifying a population of LIFEPAK 15 customers of an issue that may cause their devices to fail to deliver a defibrillation shock after the "Shock" button on the keypad is pressed. This is a result of oxidation that may have formed over time within the "Shock" button.
    • Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators.
  2. 2019

    Stryker 对 LIFEPAK 15 设备启动纠正措施

    整改

    Stryker 宣布对部分 LIFEPAK 15 监护除颤仪采取自愿现场纠正措施。相关问题可能导致设备在按下“Shock”按钮后无法放电。Stryker 表示将联系受影响客户安排纠正措施,包括更换受影响的键盘。

    品牌回应

    • 整改 — Stryker

      The company is contacting customers with impacted devices to schedule the correction of their device(s), which will include replacement of the affected keypad.

    来源摘录

    • Company Announcement Date: December 27, 2019
    • Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators.
    • The company is notifying a population of LIFEPAK 15 customers of an issue that may cause their devices to fail to deliver a defibrillation shock after the “Shock” button on the keypad is pressed.
  3. 2018

    《反海外腐败法》处罚

    公司因涉嫌未能发现和防止涉及印度、中国和科威特销售中的不当付款风险而支付罚款。

  4. 2013

    海外腐败和解

    史赛克解决了与阿根廷、希腊、墨西哥、波兰和罗马尼亚销售活动相关的不当付款指控。

  5. 2012

    Neptune废物管理系统召回

    在发生致命事故以及对某些设备缺乏所需FDA许可的担忧之后,多个Neptune医疗真空型号被召回。

  6. 2012

    Rejuvenate和ABG II髋关节系统争议

    史赛克的Rejuvenate和ABG II髋关节置换系统在报告称这些设备可能导致严重疼痛和其他并发症后,成为FDA行动、召回相关后果、诉讼和罚款的对象。

  7. 2008

    FDA文件记录和生物技术设施问题

    FDA指出马萨诸塞州生物技术设施的质量和合规问题,包括产品文件记录问题。史赛克表示,参与伪造记录的员工已被解雇。

  8. 2007

    FDA制造和合规警告

    FDA警告信指出了史赛克在爱尔兰和新泽西工厂的质量体系、制造、测试和纠正措施问题。