Device product
STREAMLAB - REFRIGERATED STORAGE MODULE 15000
Z-0217-2019
Product summary
- Event
- Event 81047
- Status
- Terminated
- Classification
- Class II
- Quantity
- 186 StreamLAB Automation Modules
- Official record key
device-enforcement:Z-0217-2019
Official wording
Reason: The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
Code information: Siemens Material Numbers: 10482428; UDI: 00630414949765
Distribution pattern: The products were distributed to the following US states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV. The products were distributed to the following foreign countries: Australia, Austria, Bangladesh, Belgium, Canada, Croatia, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Libya, Netherlands, Philippines, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Taiwan, Thaliand, UAE, UK.
Derived failure modes
-
Unknown
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.