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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

Mandated?Voluntary: Firm initiated
Recall NumberZ-1870-2021
Event ID87953
Event DescriptionAtellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Product TypeDevices
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.
Quantity2,153 units
Recall ReasonPhotometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results
Device Classification20210623
Device Code InfoSoftware version: 1.24.0 SP1 or lower
Center Classification Date20210616
Recall Initiation Date20210504
Recalling FirmSiemens Healthcare Diagnostics, Inc.
Initial Notification Letter
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