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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71177

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

Open FDA event record

Event summary

Timeline bucket
March 16, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems (Cleveland) 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

11 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 11

MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-1647-2015
Recall number
Z-1647-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Quantity
153 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Code information

MX8000 Dual v. EXP: System Code #, 728130, Serial #, 8107, 8128, 8152, 8157, 8171, 8212, 8236, 8245, 8263, 8320 & 8357.

Distribution pattern

Distributed in China.

device · product 2 of 11

Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-1648-2015
Recall number
Z-1648-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Quantity
153 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Code information

System Code #, 728243, Serial #, 7039

Distribution pattern

Distributed in China.

device · product 3 of 11

Brilliance CT 64. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-1649-2015
Recall number
Z-1649-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Quantity
153 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Code information

System Code #, 728231, Serial #, 9568, 9758, 10097, 10143, 10267, 10269, 10275, 10427, 10436, 10521, 10545, 10579, 10622, 90097, 90218, 95203, 95319, 95328, 95362, 95369, 95391, 95414, 95427, 95433, 95471, 95486, 95544, 95586, 95604, 95605, 95617, 95628, 95632, 95640, 95672, 95752, 95754 & 95757.

Distribution pattern

Distributed in China.

device · product 4 of 11

Brilliance CT 40. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-1650-2015
Recall number
Z-1650-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Quantity
153 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Code information

System Code #, 728235, Serial #, 90071 & 90178.

Distribution pattern

Distributed in China.

device · product 5 of 11

Brilliance CT 16 Power. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-1651-2015
Recall number
Z-1651-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Quantity
153 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Code information

System Code #, 728240, Serial #, 60008.

Distribution pattern

Distributed in China.

device · product 6 of 11

Brilliance CT 16 Water. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-1652-2015
Recall number
Z-1652-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Quantity
153 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Code information

System Code #, 728245, Serial #, 3500.

Distribution pattern

Distributed in China.

device · product 7 of 11

Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-1653-2015
Recall number
Z-1653-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Quantity
153 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Code information

System Code #, 728246, Serial #, 3376, 3393, 3444, 3466, 3650, 4055, 5234, 5239, 5311, 5366, 5387, 5388, 5403, 5408, 5417, 5418, 5420, 5421, 5422, 5427, 5450, 5483, 5484, 5497, 5503, 5507, 5574, 5610, 5614, 5626, 5639, 5692, 5729, 5736, 5800, 5804, 5853, 5905, 5909, 5925, 5927, 5989, 5993, 6128, 6149, 6232, 6308, 6313, 6322, 6351, 6384, 6389, 6462, 6488, 6604, 30061, 50002, 50033, 50048, 50062, 50065, 50069, 50080, 50095, 50097, 50099, 50137 & 500006.

Distribution pattern

Distributed in China.

device · product 8 of 11

Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-1654-2015
Recall number
Z-1654-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Quantity
153 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Code information

System Code #, 728256, Serial #, 2448, 3145, 3212, 3213, 3276, 3278, 280, 3307, 3309, 3317, 3336, 30003, 30008, 30017, 30021, 30022, 30036 & 30047.

Distribution pattern

Distributed in China.

device · product 9 of 11

Brilliance CT 6 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-1655-2015
Recall number
Z-1655-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Quantity
153 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Code information

System Code #, 728256, Serial #, 2448, 3145, 3212, 3213, 3276, 3278, 280, 3307, 3309, 3317, 3336, 30003, 30008, 30017, 30021, 30022, 30036 & 30047.

Distribution pattern

Distributed in China.

device · product 10 of 11

Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-1656-2015
Recall number
Z-1656-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Quantity
153 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Code information

System Code #, 728306, Serial #, 100067, 100137, 100179, 100226, 100233, 100293, 100294 & 100342.

Distribution pattern

Distributed in China.

device · product 11 of 11

Ingenuity CT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-1657-2015
Recall number
Z-1657-2015
Initiated
March 16, 2015
Classification
Class II
Status
Terminated
Quantity
153 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.

Code information

System Code #, 728326, Serial #, 300130.

Distribution pattern

Distributed in China.