Spacelabs Recalls G2 Clinical Access Software CDs Due to Incorrect Programs
Spacelabs Healthcare is voluntarily recalling G2 Clinical Access Software CDs because they contain incorrect programs, preventing customers from installing the software.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary action for a software installation defect that prevents software installation but does not pose a direct physical safety hazard or report injuries.
Plain-English summary
Spacelabs Healthcare, LLC has voluntarily recalled G2 Clinical Access Software CDs. The affected products include the G2 Clinical Access CD (Part Number: 063-1829-11 Rev A) and the Update Kit (Part Number: 040-1565-10). These CDs are used for installing ICS G2 Clinical Access software onto hospital personal computers.
The recall was initiated because the programs installed on the Clinical Access CD are incorrect. This defect prevents customers from successfully installing the Clinical Access software. The agency classification for this recall is Class II.
A total of 36 units were distributed worldwide, with 17 units distributed in the United States and 19 units distributed outside the United States. The US distribution included Alabama, Florida, Georgia, Louisiana, Missouri, New York, South Carolina, Tennessee, Texas, and Wyoming. International distribution included Australia, Canada, Czechoslovakia, China, Colombia, France, Great Britain, Italy, Netherlands, Poland, Saudi Arabia, and Turkey. Affected serial numbers include "040-1565-10" and "063-1829-11".
The recalled product
- Product
- Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers.
- Manufacturer
- Spacelabs Healthcare, Llc
- Hazard
Distribution
Related recalls
Same manufacturer · Spacelabs Healthcare, Llc
See all →- HighSpacelabs AriaTelemetry Transmitters Recalled for SpO2 Display Errors
FDA (Devices) · 2014-02-05
- HighSpacelabs qube Patient Monitor Recalled for Power-On Failure
FDA (Devices) · 2013-11-27
- ModerateSpacelabs elance Vital Signs Monitor Recalled Due to Sensor Connection Failure
FDA (Devices) · 2013-11-20
- HighSpacelabs Smart Disclosure System Recalled for Incorrect Waveform Display
FDA (Devices) · 2013-01-23
- HighSpacelabs Qube Compact Patient Monitor Recalled for Input Circuit Failure
FDA (Devices) · 2012-11-28
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighSpacelabs Smart Disclosure System Recalled for Patient Data Mismatch
FDA (Devices) · 2019-07-31
- HighSpacelabs Smart Disclosure System Recalled for Incorrect Waveform Display
FDA (Devices) · 2013-01-23
- HighCardiology records system recalled over data saved to the wrong patient
FDA (Devices) · 2025-11-12
- HighMedtronic CareLink 2090 Programmer Recalled for Software Vulnerability
FDA (Devices) · 2018-11-14
- HighGE Healthcare Recalls Centricity PACS Foundation Software
FDA (Devices) · 2019-07-10
- HighGe Healthcare Recalls Imagecast PACS Software Due to Image Context Defect
FDA (Devices) · 2016-08-03