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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68588

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

Open FDA event record

Event summary

Timeline bucket
June 13, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems, Inc.

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

4 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 4

Ingenia 3.0T R5, magnetic resonance imaging system.

Z-1862-2014
Recall number
Z-1862-2014
Initiated
June 13, 2014
Classification
Class II
Status
Terminated
Quantity
21

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Code information

Model Numbers: 781342

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, GA, ME, MI, NY, OH, PA, TX, and WA, and the countries of Mexico, Argentina, Australia, Belarus, Belgium, Brazil, Chile, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Laos, New Zealand, Norway, Palau, Poland, Portugal, Qatar, South Africa, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Turkey, United Kingdom, Venezuela, and Vietnam.

device · product 2 of 4

Ingenia 1.5T R5, magnetic resonance imaging system.

Z-1863-2014
Recall number
Z-1863-2014
Initiated
June 13, 2014
Classification
Class II
Status
Terminated
Quantity
33

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Code information

Model Number: 781341

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, GA, ME, MI, NY, OH, PA, TX, and WA, and the countries of Mexico, Argentina, Australia, Belarus, Belgium, Brazil, Chile, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Laos, New Zealand, Norway, Palau, Poland, Portugal, Qatar, South Africa, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Turkey, United Kingdom, Venezuela, and Vietnam.

device · product 3 of 4

Ingenia 3.0T, magnetic resonance imaging system.

Z-1864-2014
Recall number
Z-1864-2014
Initiated
June 13, 2014
Classification
Class II
Status
Terminated
Quantity
18

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Code information

Model Number: 781377

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, GA, ME, MI, NY, OH, PA, TX, and WA, and the countries of Mexico, Argentina, Australia, Belarus, Belgium, Brazil, Chile, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Laos, New Zealand, Norway, Palau, Poland, Portugal, Qatar, South Africa, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Turkey, United Kingdom, Venezuela, and Vietnam.

device · product 4 of 4

Ingenia 1.5T, magnetic resonance imaging system.

Z-1865-2014
Recall number
Z-1865-2014
Initiated
June 13, 2014
Classification
Class II
Status
Terminated
Quantity
24

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

Code information

Model Number: 781396

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, GA, ME, MI, NY, OH, PA, TX, and WA, and the countries of Mexico, Argentina, Australia, Belarus, Belgium, Brazil, Chile, China, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, South Korea, Laos, New Zealand, Norway, Palau, Poland, Portugal, Qatar, South Africa, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Turkey, United Kingdom, Venezuela, and Vietnam.