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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94647

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

Open FDA event record

Event summary

Timeline bucket
May 16, 2024
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

3 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 3

Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.

Z-1895-2024
Recall number
Z-1895-2024
Initiated
May 16, 2024
Classification
Class II
Status
Ongoing
Quantity
1 unit (US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

Code information

Product number: 722012, UDI/DI: 00884838059054; Serial Number: 2138.

Distribution pattern

Domestic: OK International: India, Spain, U.A.E.

device · product 2 of 3

Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.

Z-1896-2024
Recall number
Z-1896-2024
Initiated
May 16, 2024
Classification
Class II
Status
Ongoing
Quantity
3 units (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

Code information

Product number: 722010, UDI/DI: 00884838059030; Serial Numbers: 774, 909, 526.

Distribution pattern

Domestic: OK International: India, Spain, U.A.E.

device · product 3 of 3

Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.

Z-1897-2024
Recall number
Z-1897-2024
Initiated
May 16, 2024
Classification
Class II
Status
Ongoing
Quantity
1 unit (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

Code information

Product number: 722013, UDI/DI: 00884838059061; Serial Number: 232.

Distribution pattern

Domestic: OK International: India, Spain, U.A.E.