Recall Z-1003-2013— Philips Healthcare Inc.
Class II · Terminated
Class II FDA medical device recall by Philips Healthcare Inc., initiated 2010-04-05, terminated 2021-03-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Philips Healthcare Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2010-04-05
- Terminated
- 2021-03-08
- Firm location
- Andover, MA, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.