FDA recall Z-2035-2019

Product

Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.

Reason for recall

Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2019-01-28

Report date

2019-07-31

Termination date

2022-02-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Snoqualmie, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2035-2019