CLASS II Device recall · Reported 11 Jun 2014 · FDA Enforcement Report

The NAV3i Platform Power Box supplies the electrical recalled

Stryker Instruments Div. of Stryker is recalling The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker, distributed in 10 states. The recall was initiated on 13 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesStryker Product Number: 7700-853-000 Stryker Serial Numbers: 10004
Quantity recalled20

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-1716-2014
FDA event ID
68261
Recalling firm
Stryker Instruments Div. of Stryker, Portage, MI
Classification
Class II
Status
Terminated
Recall initiated
13 May 2014
FDA classified
4 Jun 2014
Reported
11 Jun 2014
Type
Voluntary: Firm initiated
Reason category
Other Reasons
Device type
Patient Monitors

Timeline

13 May 2014Recall initiated by company
4 Jun 2014Classified by FDA+22 days
11 Jun 2014Published in enforcement report+7 days

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

Reason for recall

The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints

Product as listed by the FDA

The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).

Where it was distributed

Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.

ArkansasCaliforniaIndianaLouisianaMassachusettsMarylandMichiganMontanaNevadaTexas

Questions about this recall

Why was it recalled?

The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints

Which lots are affected?

Stryker Product Number: 7700-853-000 Stryker Serial Numbers: 10004

Where was it sold?

Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.

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.

Other products in this recall event

1 other product · FDA event 68261

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