Z-1299-2019 Class II Terminated
FDA device recall Z-1299-2019 was initiated by Siemens Healthcare Diagnostics, Inc. on March 7, 2019 and is designated Class II. Reason for recall: There were multiple issues identified in the system software which required an update. The recall status is terminated (terminated August 20, 2020). Affected quantity: 277.
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2019
- Initiation Date
- March 7, 2019
- Termination Date
- August 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 277
Product Description
Reason for Recall
Distribution Pattern
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Pakistan, Poland, Portugal Republic of Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, and Vietnam.