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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71647

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

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Event summary

Timeline bucket
July 06, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Electronics North America Corporation

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

Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the following products: 722001 Allura Xper FD 10 C; 722003 Allura Xper FD10; 722005 Allura Xper FD10/10; 722006 Allura Xper FD20; 722008 Allura Xper FD20 Biplane; 722010 Allura Xper FD10; 722011 Allura Xper FD10/10; 722012 Allura Xper FD20; 722013 Allura XPER FD20 BIPLANE; 722015 Allura Xper FD20 OR Table; 722020 Allura Xper FD20 Biplane OR Table; 722022 Allura Xper FD10 OR Table; 722023 Allura Xper FD20 OR Table; 722025 Allura Xper FD20 Biplane OR Table; 722026 Allura Xper FD10; 722027 Allura Xper FD10/10; 722028 Allura Xper FD20; 722029 Allura Xper FD20/10; 722035 Allura Xper FD20 OR Table; 722038 Allura Xper FD20/20; 722039 Allura Xper FD20/20 OR Table; 722058 Allura Xper FD20/15; 722123 Field extensions Xper cardio R7.6; 722124 Field extensions Xper vascular R7.6; 722133 Field ext. Xper cardio systems R7.6; 722134 Field ext. Xper vascular systems R7.6; 72249 INTEGRIS BV5000; 722043 INTEGRIS Allura 15-12 (mono); 722121 Field extensions INTEGRIS cardio systems

Z-0810-2016
Recall number
Z-0810-2016
Initiated
July 06, 2015
Classification
Class II
Status
Terminated
Quantity
3158 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.

Code information

Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122

Distribution pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of : Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cayman Islands, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, Netherlands Antilles, New Zealand, Norway, Oman, Pakistan, occupied Palestinian territory, Panama, PERU, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom and Viet Nam.