FDA Medical Device Recalls (openFDA)
Spacelabs Healthcare, Inc.: Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
- Recall number
- Z-2035-2019
- Recalling firm
- Spacelabs Healthcare, Inc.
- Product
- Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
- Status
- Terminated
- Initiated
- 2019-01-28
- Posted
- not on file
- Terminated
- 2022-02-24
- Reason
- Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
- Root cause
- Software design
- Action
- The recalling firm began issuing customer letters on 1/28/2019 via priority service, return receipt requested, to all U.S. customers. The letter was translated, as necessary, and emailed on 2/4/2019 to the international subsidiaries and distributors. The firm identified 6 new customers (5 U.S. and 1 international) and the letter for the 5 new U.S. customers was issued 5/30/2019 via priority service, return receipt requested. The letter for the 1 new international customer was emailed on 5/28/2019.
- Quantity
- 295 customer sites have the affected software versions
- 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.
- Lot, serial or model codes
- All affected Smart Disclosure installations with software versions 5.00, 5.01, 5.02, or 5.03, UDI 10841522123580.
- 510(k) numbers
- ["K110779"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 3010157426
- Firm city
- Snoqualmie
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28