Atellica CH 930 Analyzer with Photometer Lamp recall
Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
Why was Atellica CH 930 Analyzer with Photometer Lamp recalled?
Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software version: 1.24.0 SP1 or lower
- Product
- Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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, 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.
- Recall date
- June 23, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)