Exact FDA event identifier

Event 65666

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: June 21, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Picis Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes.

Z-1814-2013

Recall number: Z-1814-2013
Initiated: June 21, 2013
Classification: Class II
Status: Terminated
Recalling firm: Picis Inc.
Quantity: 35

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Notes associated with prescription are not printed to the prescription or to the patient chart.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Notes associated with prescription are not printed to the prescription or to the patient chart.

Code information

Software Versions 5.2 and 5.3

Distribution pattern

Nationwide Distribution, including the states of: AK, AR, AZ, CA, CO, DC, DE, FL, GA, ID, IN, MA, MD, MO, NH, NJ, OH, OR, SC, TN, WA, and WV.