Z-2035-2019Class II

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

Name: Z-2035-2019 Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2
Creator: Spacelabs Healthcare, Inc.
Published: 2019-01-28
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-01-28 / Terminated / root cause: software

FDA source

Spacelabs Healthcare, Inc. began a recall of Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2 on 2019-01-28. FDA classified it as Class II and gives the reason as "Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2035-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-28
Posted: 2019-07-22
Terminated: 2022-02-24
Recalling firm: GE Healthcare
Product: Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Product code: DQK Computer, Diagnostic, Programmable
Reason for recall: Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: All affected Smart Disclosure installations with software versions 5.00, 5.01, 5.02, or 5.03, UDI 10841522123580.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2035-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2035-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-22

Product code DQK

K110779Class IISpacelabs Smart Disclosure SystemSpacelabs Healthcare / cleared 2011-04-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)