Z-2035-2019 Class II Terminated
FDA device recall Z-2035-2019 was initiated by Spacelabs Healthcare, Inc. on January 28, 2019 and is designated Class II. Reason for recall: Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms. The recall status is terminated (terminated February 24, 2022). Affected quantity: 295 customer sites have the affected software versions.
Recall Details
- Product Type
- Devices
- Report Date
- July 31, 2019
- Initiation Date
- January 28, 2019
- Termination Date
- February 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 295 customer sites have the affected software versions
Product Description
Reason for Recall
Distribution Pattern
Distribution was nationwide. There was also government and military distribution. Foreign distribution was made to Argentina, Bahrain, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Costa Rica, Czech Republic, France, Hong Kong, India, Indonesia, Italy, Kuwait, Malaysia, Mexico, Netherlands, Pakistan, Palestine, Panama, Philippines, Poland, Qatar, Romania, Saudi Arabia, Spain, Switzerland, Taiwan, Trinidad and Tobago, Tunisia, Turkey, UAE, United Kingdom, and Viet Nam.