Philips Healthcare Inc.: Medical Device Recall in 2013 - (Recall #: Z-1003-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into cross-sectional images. Each device also includes signal analysis and display equipment, patient and equipment supports, components, and accessories.

Product Classification:

Class II

Date Initiated: April 5, 2010

Date Posted: April 24, 2013

Recall Number: Z-1003-2013

Event ID: 64708

Reason for Recall:

Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parameters stated.

Status: Terminated

Product Quantity: 2089 US 4036 ROW

Code Information:

Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore, Precedence SPECT/CT, Brilliance CT (6, 10,16, 16P, 40, 64, and Big Bore), Brilliance iCT, Brilliance iCT SP

Distribution Pattern:

Worldwide Distribution including USA (nationwide)

Voluntary or Mandated:

Voluntary: Firm initiated