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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89174

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

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Event summary

Timeline bucket
November 12, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips North America Llc

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

Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224

Z-0471-2022
Recall number
Z-0471-2022
Initiated
November 12, 2021
Classification
Class II
Status
Terminated
Recalling firm
Philips North America Llc
Quantity
10 units (1 US and 9 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available

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

(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available

Code information

US: Model 722068 Azurion 7 B20 S/N: 109 UDI: (01)00884838085367(21)109. OUS: Model: S/N UDI: 722226 Azurion 7 B20 176 (01)00884838099272(21)176; 722228 Azurion 5 M20 3 (01)00884838099234(21)3; 722221 Azurion 3 M12 8 (01)00884838099203(21)8; 722225 Azurion 7 B12 16 (01)00884838099265(21)16; 722225 Azurion 7 B12 73 (01)00884838099265(21)73; 722226 Azurion 7 B20 42 (01)00884838099272(21)42; 722226 Azurion 7 B20 157 (01)00884838099272(21)157; 722224 Azurion 7 M20 293 (01)00884838099258(21)293; 722078 Azurion 7 M12 220 (01)00884838085251(21)220

Distribution pattern

Worldwide distribution - US Nationwide distribution in the state of WA and the countries of France, Germany, Japan, Poland, United Kingdom.