Z-0997-2022 Class II Terminated
FDA device recall Z-0997-2022 was initiated by Siemens Medical Solutions USA, Inc on Mar 7, 2022 and is designated Class II. Reason for recall: Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient… The recall status is terminated (terminated Dec 19, 2023). Affected quantity: 14 (US).
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2022
- Initiation Date
- Mar 7, 2022
- Termination Date
- Dec 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 (US)
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, VA and the countries of Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Switzerland, United Kingdom.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0997-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026