—#187504

Product

Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000

FDA product code: JGS — Electrode, Ion Specific, Sodium
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K151767
Affected lot / code info: Software version: 1.24.0 SP1 or lower

Why it was recalled

Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results

Root cause (FDA determination)

Device Design

Action the firm took

Siemens 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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: Worldwide 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.

Timeline

Recall initiated: 2021-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187504. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.