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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91806

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 20, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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

2 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 2

SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6

Z-1416-2023
Recall number
Z-1416-2023
Initiated
February 20, 2023
Classification
Class II
Status
Ongoing
Quantity
1461 units (236 US, 1225 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

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

There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

Code information

UDI: (01)00884838088566 SmartPerfusion with Allura Xper or Azurion model number: 722003, 722006, 722008, 722010, 722012, 722013, 722020, 722023, 722026, 722027 722028, 722029, 722035, 722038, 722039, 722058, 722059, 722064, 722067 722068, 722078, 722079, 722223, 722224, 722225, 722226, 722227 and 722228. Software license key: 459801530271 sw key SmartPerfusion

Distribution pattern

Worldwide - US Nationwide distribution.

device · product 2 of 2

2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1

Z-1417-2023
Recall number
Z-1417-2023
Initiated
February 20, 2023
Classification
Class II
Status
Ongoing
Quantity
549 units (75 US, 474 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

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

There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

Code information

UDI: (01)00884838059276 2D Perfusion with Allura Xper or Azurion model number: 722003, 722006, 722008, 722010, 722012, 722013, 722020, 722023, 722026, 722027 722028, 722029, 722035, 722038, 722039, 722058, 722059, 722064, 722067 722068, 722078, 722079, 722223, 722224, 722225, 722226, 722227 and 722228. Software License Keys: 459801071511 sw key 2D Perfusion (IW) 459800240601 sw key 2D Perfusion (XV)

Distribution pattern

Worldwide - US Nationwide distribution.