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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93574

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

Open FDA event record

Event summary

Timeline bucket
December 23, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Philips Healthcare (Suzhou) Co., Ltd.

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

Incisive CT, model 728143 & 728144 running Software Version 5.0.0.

Z-0640-2024
Recall number
Z-0640-2024
Initiated
December 23, 2022
Classification
Class II
Status
Ongoing
Quantity
828

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
defect where the error couch motion signal of couch firmware

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

Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.

Code information

UDI-DI: 00884838085015 (Model 728143) UDI-DI: 00884838105508 (Model 728144)

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VT, WI, & Puerto Rico and the countries of Albania, Algeria, Argentina, Australia, Austria, Bhutan, Bolivia, Bosnia-Herz, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Mauritius, Moldova, Morocco, Netherlands, New Zealand, Norway, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Saint Kitts, Saint Lucia, Saudi Arabia, Senegal, Serbia, Sint Maarten, Slovakia, South Africa, South Korea, Spain, St. Pier Miquel, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, United Arab Emirates, Uzbekistan, Venezuela, & Vietnam.