Siemens Healthcare Diagnostics, Inc. Recall 87953
Description: Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Siemens Healthcare Diagnostics, Inc. Recall 87953 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1870-2021 |
| Event ID | 87953 |
| Event Description | Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000 |
| Product Type | Devices |
| 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, 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. |
| Quantity | 2,153 units |
| Recall Reason | Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results |
| Device Classification | 20210623 |
| Device Code Info | Software version: 1.24.0 SP1 or lower |
| Center Classification Date | 20210616 |
| Recall Initiation Date | 20210504 |
| Recalling Firm | Siemens Healthcare Diagnostics, Inc. |
| Initial Notification | Letter |
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