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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens

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 Class 2 Device Recall Siemenssee related information
Date Initiated by FirmMay 04, 2021
Create DateJune 16, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1870-2021
Recall Event ID 87953
510(K)NumberK151767 
Product Classification Electrode, ion specific, sodium - Product Code JGS
ProductAtellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Code Information Software version: 1.24.0 SP1 or lower
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information ContactSAME
914-631-8000
Manufacturer Reason
for Recall		Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results
FDA Determined
Cause 2		Device Design
ActionSiemens issued Urgent Field Safety Notice on May 4, 2021 domestically and abroad. The Urgent Medical Device Correction (UMDC), ASI21-03.A.US, was mailed to all affected US customers via FedEx. The Urgent Field Safety Notice (UFSN), ASI21-03.A.OUS, was issued electronically to all OUS Siemens sites with affected customers for distribution and regional reporting to their local competent authorities. Letter states reason for correction, health risk and action to take: If the Atellica CH 930 Analyzer in your laboratory posts event code 04 474 04 58, in the Operator Event Log, with the message, Photometer lamp intensity is low on at least one wavelength. Perform the Lamp Replacement routine in Operator diagnostics, stop the analyzer and replace the source lamp utilizing the Lamp Replacement routine, as prompted by the event message. Instructions for the Lamp Replacement routine are available by following the link in the event code message or by accessing the online help procedure, Replacing the Source Lamp. After the lamp has been replaced, any tests completed after the error message initially posted must be repeated. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Additional Information The Atellica Solution software will be updated to flag results for this unexpected lamp failure mode to address cases where a user may delay in responding to the lamp intensity event codes and alerts. Version 1.25.0, which is under development, will be available for installation on your analyzer soon. Please retain this letter with your laboratory records and forward this letter to those who may have received t
Quantity in Commerce2,153 units
DistributionWorldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Colombia, Croatia Cura¿ao, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Oman, P.R. China Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., Uganda, United Kingdom, Uruguay, Vatikancity, Vietnam.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JGS
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