Streamlab Core Unit / Lynx with IOM recall
STREAMLAB CORE UNIT / LYNX WITH IOM
Why was Streamlab Core Unit / Lynx with IOM recalled?
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Siemens Material Numbers: 10444806; UDI: 00630414949765
- Product
- STREAMLAB CORE UNIT / LYNX WITH IOM
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 186 StreamLAB Automation Modules
- Distribution
- 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.
- Recall date
- October 31, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)