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Class 2 Device Recall APTIO INPUT/OUTPUT MODULE |
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Date Initiated by Firm |
August 14, 2018 |
Create Date |
October 23, 2018 |
Recall Status1 |
Terminated 3 on September 04, 2020 |
Recall Number |
Z-0209-2019 |
Recall Event ID |
81047 |
Product Classification |
Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
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Product |
APTIO INPUT/OUTPUT MODULE |
Code Information |
Siemens Material Numbers: 10703031, 10713760, 10713775, 10713772; UDI: 00630414594477 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
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For Additional Information Contact |
914-631-8000
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Manufacturer Reason for Recall |
The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Urgent Medical Device Correction notification letters dated 8/14/18 were distributed to customers. |
Quantity in Commerce |
441 Aptio 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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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