Spacelabs Healthcare, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2035-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 28, 2019

Date Posted: July 31, 2019

Recall Number: Z-2035-2019

Event ID: 83220

Reason for Recall:

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

Status: Terminated

Product Quantity: 295 customer sites have the affected software versions

Code Information:

All affected Smart Disclosure installations with software versions 5.00, 5.01, 5.02, or 5.03, UDI 10841522123580.

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.

Voluntary or Mandated:

Voluntary: Firm initiated