Z-1537-2017 Class II Terminated
FDA device recall Z-1537-2017 was initiated by Siemens Healthcare Diagnostics, Inc. on February 2, 2017 and is designated Class II. Reason for recall: Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent delay to testing when these issues occur. The software issues affecting the analyzer may … The recall status is terminated (terminated June 22, 2018). Affected quantity: US: 17 units; Foreign: 712 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 29, 2017
- Initiation Date
- February 2, 2017
- Termination Date
- June 22, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 17 units; Foreign: 712 units
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Distribution to the states of : NH, MD, MS, MN, IL, TX, CA and WA, and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Latvia, Malaysia, Myanmar, Netherlands, New Zealand, Norway, P.R. China, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Uruguay, Vatican City, and Vietnam.