Recall Z-1870-2021 · JGS Electrode, Ion Specific, Sodium
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
| Date | May 4, 2021 |
| Status | Open, Classified |
| Reason | Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results |
| Root cause | Device Design |
| Action | 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, Ph |
| Quantity | 2,153 units |
| Distribution | 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, Hon |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151767 | Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Br Siemens Healthcare Diagnostics, Inc., Dec 11, 2015 |