PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: June 23, 2021 Initiated: May 4, 2021 #Z-1870-2021

Product Description

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

Reason for Recall

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

Details

Units Affected
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, 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.
Location
Tarrytown, NY

Frequently Asked Questions

What product was recalled?
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 2,153 units.
Why was this product recalled?
Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results
Which agency issued this recall?
This recall was issued by the FDA Devices on June 23, 2021. Severity: Moderate. Recall number: Z-1870-2021.