FDA Device recall Z-2035-2019
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2
- FDA Device
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2 by Spacelabs Healthcare, citing several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2035-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-28 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Spacelabs Healthcare |
| Distribution | US |
Product
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Reason
Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
Identifiers
| code_info | All affected Smart Disclosure installations with software versions 5.00, 5.01, 5.02, or 5.03, UDI 10841522123580. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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All Spacelabs Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2035-2019%22
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