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
Digital Image Storage Radiological Device - Product Code LMB
원인
Guardian services data backup does not contain 100% data for all orthopad customers on a daily basis.
조치
Firm notified consignees by an Urgent: Device Correction letter, dated 7/31/2009. The letter states the problem and that Stryker is upgrading its internal infrastructure to remediate the problem. The letter also states the firm's recommendations to reduce risk to patients. Stryker will not bill customers for the Guardian service until the problem is remediated and the firm notifies customers. If there are any questions, customers are to contact the firm at 972-410-7100.
Guardian Services, Guardian Software, Part Number 0240-009-430 (Guardian Services) with Part Numbers 0250-003-016, 0250-003-017 and 0250-003-018 (OrthoPad) || Intended use of Guardian Services is to act as a medical data backup and disaster recovery plan.