Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87273

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

Open FDA event record

Event summary

Timeline bucket
January 27, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Medical Solutions USA, 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

Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161 SIS Server 6648153

Z-1173-2021
Recall number
Z-1173-2021
Initiated
January 27, 2021
Classification
Class II
Status
Terminated
Quantity
37 US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system

Code information

Software version VD12 and equipped with HP Flex Pro-C PC Serial Numbers: 10704 18900 18901 103008 103014 103019 103022 103039 103040 103042 103047 103048 103053 103079 103080 103082 103086 103088 103089 103090 103115 103116 103117 103119 103123 103124 103130 103131 103137 103144 103145 103148 103152 103160 103170 103171 123004

Distribution pattern

US Nationwide distribution in the states of AK, AR, CA, GU, IA, IL, MI, MO, NC, NE, OR, PA, PA, PR, SD, TN, TX, WA.