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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87978

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

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Event summary

Timeline bucket
June 23, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems Nederlands

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 Allura Xper System: Interventional Fluoroscopic X-Ray System Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058.

Z-1904-2021
Recall number
Z-1904-2021
Initiated
June 23, 2016
Classification
Class II
Status
Terminated
Quantity
42 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain low-voltage DC power supplies (DCPS) used in these products may be subject to an increased probability of failure. Failure of a DCPS may result in the sudden loss of imaging functionality or mechanical movement, depending on what subsystems the DCPS is powering.

Code information

Product No.: 722026, 722027, 722028, 722029, 722035, 722038, and 722058. Date(s) of Distribution: 16-SEP-2014 - 04-MAY-2016. System equipment numbers: 64937259 65862117 63304032 63151474 63250793 63303889 63304149 64140063 63855729 63516113 64077887 66407452 66350303 65342973 63210187 63511276; 66923399 66422060 64085323 61099178 64103799 67936786 66730784 66736708 66628236 63883590 64916638 64927462 65345691 66517161 66403768 63218881 67360962 69856976 65258983 66167983 64778594 61655917 65206981 67874859

Distribution pattern

Worldwide distribution. US states of: AL, AZ, FL, GA, IL, MA, MO, NJ, OR, and VA; Netherlands, United Kingdom, Poland, Spain, France, Czech Republic, India, Brazil, Singapore, Japan, Colombia, United Arab Emirates, China, Russian Federation, Oman, and Mexico.