Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2190-2019·Announced 2019-08-14

Philips iCT SP Computed Tomography Systems Recalled for Image Labeling Error

Philips is recalling 27 iCT SP computed tomography systems because images may be incorrectly labeled as having phase tolerance applied when it was not.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a labeling error that could lead to misinterpretation of images rather than direct physical injury, fitting the criteria for moderate severity.

Plain-English summary

Philips Medical Systems (Cleveland) Inc is recalling 27 iCT SP Model # 728311 computed tomography x-ray systems. The recall is due to a software issue where, during certain cardiac step and shoot acquisitions with phase tolerance selected, images may be labeled as if phase tolerance had been applied when it had not actually been applied.

The affected systems were distributed worldwide, including the United States, Puerto Rico, Canada, Mexico, and numerous other countries. The recall covers specific system serial numbers, including ranges such as 83001-83006, 100109, and 200003 through 200069.

Healthcare providers should contact Philips Medical Systems for instructions on how to resolve the issue. Patients who have had imaging performed on these systems should consult their healthcare provider to determine if the labeling error affects their specific diagnostic results.

The recalled product

Product: iCT SP Model # 728311, computed tomography x-ray system
Manufacturer: Philips Medical Systems (Cleveland) Inc
Category: Medical Device — Imaging Equipment
Hazard: mis-labeling
Affected units: 27

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

System Serial Number 83001- 83006
100109
200003 through 200069
200071
200073 through 200138
200200 through 200217
200000261
200206
314329
713513

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 9 recalled by Philips Medical Systems (Cleveland) Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · Philips Medical Systems (Cleveland) Inc

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Same hazard · mis labeling