Events

Recall of Device Recall Stryker Video Cart with Isolation Transformer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Endoscopy.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30763
  • Event Risk Class
    Class 3
  • Event Number
    Z-0417-05
  • Event Initiated Date
    2004-11-30
  • Event Date Posted
    2005-01-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36549
  • Notes / Alerts
    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.
  • Extra notes in the data
    Laparoscope, General & Plastic Surgery - Product Code GCJ
  • Reason
    A problem with the design of the transformers may cause the transformers' circuit breakers to trip, which could result in loss of power to connected medical devices.
  • Action
    The firm has initiated consignee notification by sending a notification letter and acknowledgement of receipt cards to its consignees. Service cards will be issued to firm sales representatives.

Device

Device Recall Stryker Video Cart with Isolation Transformer
  • Model / Serial
    Model numbers 240-099-011- Serial numbers 031111001-021, 040114001-029, 040130001-007, 040308001-023, 040322001-010, 040412001-020. 240-099-012- serial numbers 040130008-022, 040311001-015, 040322001-010, 040401001, 002, 004 and 005. 240-099-020-serial numbers 040212001-032, 040309001-007, 040313001-010. 240-099-021-serial numbers 040224001-021, 040313017. 240-099-050-serial numbers 031218001-005, 031218031-045
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were distributed to 114 consignees.
  • Product Description
    Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold separately.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA