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U.S. Department of Health and Human Services

Class 2 Device Recall STREAMLAB REFRIGERATED STORAGE MODULE 9000

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 Class 2 Device Recall STREAMLAB REFRIGERATED STORAGE MODULE 9000see related information
Date Initiated by FirmAugust 14, 2018
Create DateOctober 23, 2018
Recall Status1 Terminated 3 on September 04, 2020
Recall NumberZ-0216-2019
Recall Event ID 81047
510(K)NumberK082638 
Product Classification Equipment, laboratory, general purpose, labeled or promoted for a specific medical use - Product Code LXG
ProductSTREAMLAB - REFRIGERATED STORAGE MODULE 9000
Code Information Siemens Material Numbers: 10482426, 10464532, 10635930; UDI: 00630414949765
FEI Number 2432235
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
914-631-8000
Manufacturer Reason
for Recall		The modules may have been shipped without a warning label for potential risk of interference to pacemaker functionality.
FDA Determined
Cause 2		Under Investigation by firm
ActionUrgent Medical Device Correction notification letters dated 8/14/18 were distributed to customers.
Quantity in Commerce186 StreamLAB Automation Modules
DistributionThe 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 CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = LXG
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