CLASS II Device recall · Reported 31 Jul 2019 · FDA Enforcement Report

Smart Disclosure System recalled by Spacelabs Healthcare

Spacelabs Healthcare is recalling Smart Disclosure System, distributed nationwide in the US. The recall was initiated on 28 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll affected Smart Disclosure installations with software versions 5.00, 5.01, 5.02, or 5.03, UDI 10841522123580.

Quantity recalled295 customer sites have the affected software versions

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2035-2019
FDA event ID: 83220
Recalling firm: Spacelabs Healthcare, Snoqualmie, WA
Classification: Class II
Status: Terminated
Recall initiated: 28 Jan 2019
FDA classified: 22 Jul 2019
Reported: 31 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

28 Jan 2019	Recall initiated by company
22 Jul 2019	Classified by FDA	+175 days
31 Jul 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Spacelabs Healthcare

All 47

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Xhibit Central Station recalled by Spacelabs Healthcare	Spacelabs Healthcare	Device Malfunction	Nationwide
13 May 2026Device	CLASS II	Spacelabs Ultraview SL Command Module SL Command Module recalled	Spacelabs Healthcare	Packaging Defects	Nationwide
15 Apr 2026Device	CLASS II	Multi-parameter Command Module recalled by Spacelabs Healthcare	Spacelabs Healthcare	Labeling Errors	Nationwide
12 Nov 2025Device	CLASS II	Sentinel V11 recalled by Spacelabs Healthcare	Spacelabs Healthcare	Device Malfunction	Nationwide
22 Oct 2025Device	CLASS II	Branding is not applied to this product DVI display cables recalled	Spacelabs Healthcare	Device Malfunction	Nationwide

Other Other Medical Devices recalls

All 13,908

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Plastics Tray kits recalled by Avid Medical	Avid Medical	Foreign Material	Nationwide
14 Oct 2026Device	CLASS II	Heart Prep Tray kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Pack Open Heart Cfh kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Sperm Ab Elisa (96 well plate test) recalled by DRG International	DRG International	Other	Nationwide
14 Oct 2026Device	CLASS III	BeneView Series recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide