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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71699

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

Open FDA event record

Event summary

Timeline bucket
July 01, 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

7 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 7

GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Z-2193-2015
Recall number
Z-2193-2015
Initiated
July 01, 2015
Classification
Class II
Status
Terminated
Quantity
2 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software defects in the Tumor LOC software application that may potentially result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Code information

Model #882410 GEMINI GXL 16 Slice (453567971891); Serial Number: 4170 & 4147A.

Distribution pattern

Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.

device · product 2 of 7

GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Z-2194-2015
Recall number
Z-2194-2015
Initiated
July 01, 2015
Classification
Class II
Status
Terminated
Quantity
2 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software defects in the Tumor LOC software application that may potentially result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Code information

Model #882412 GEMINI LXL (459800018631); Serial Number: 14702 & 14707.

Distribution pattern

Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.

device · product 3 of 7

GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Z-2195-2015
Recall number
Z-2195-2015
Initiated
July 01, 2015
Classification
Class II
Status
Terminated
Quantity
13 Units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software defects in the Tumor LOC software application that may potentially result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Code information

Model #882470 GEMINI TF 16 Slice (453567983931); Serial Number: 7052, 7060, 7093, 7096, 7121, 7123, 7128, 7129, 7185, 7187, 7220, 7226 & 7570.

Distribution pattern

Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.

device · product 4 of 7

GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Z-2196-2015
Recall number
Z-2196-2015
Initiated
July 01, 2015
Classification
Class II
Status
Terminated
Quantity
22 Units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software defects in the Tumor LOC software application that may potentially result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Code information

Model #882471 GEMINI TF 64 Slice (453567994741); Serial Number: 7007, 7012, 7042, 7055, 7083, 7103, 7116, 7126, 7132, 7158, 7160, 7164, 7169, 7175, 7179, 7218, 7221, 7229, 7245, 7255, 7256 & 7552.

Distribution pattern

Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.

device · product 5 of 7

GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Z-2197-2015
Recall number
Z-2197-2015
Initiated
July 01, 2015
Classification
Class II
Status
Terminated
Quantity
1 unit

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software defects in the Tumor LOC software application that may potentially result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Code information

Model #882473 GEMINI TF Ready (453567441711); Serial Number: 7237.

Distribution pattern

Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.

device · product 6 of 7

GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Z-2198-2015
Recall number
Z-2198-2015
Initiated
July 01, 2015
Classification
Class II
Status
Terminated
Quantity
2 Units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software defects in the Tumor LOC software application that may potentially result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Code information

Model #882473 GEMINI TF Base (453567441711); Serial Number: 7111 & 7150.

Distribution pattern

Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.

device · product 7 of 7

GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

Z-2199-2015
Recall number
Z-2199-2015
Initiated
July 01, 2015
Classification
Class II
Status
Terminated
Quantity
44 Units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software defects in the Tumor LOC software application that may potentially result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue.

Code information

Model #882476 GEMINI TF Big Bore (453567473391); Serial Number: 9004, 9005, 9006, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206, 9207, 9208, 9209, 9210, 9211, 9212, 9214, 9215, 9216, 9217, 9219, 9220, 9221, 9222, 9223, 9224, 9225, 9226 & 9213.

Distribution pattern

Worldwide Distribution - US Nationwide, Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Lebanon, Netherlands, Portugal, Saudi Arabia, South Africa, Switzerland, Thailand, Venezuela & Vietnam.