Philips IQon Spectral CT Scanner Recall Due to Potential Gantry Screw Failure
Philips is recalling IQon Spectral CT systems because screws holding the internal gantry to the main bearing may come loose, potentially causing noise.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural component (screws) that may fail, posing a risk of harm to patients or operators, although no injuries have been reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 50 units of the Philips Healthcare IQon Spectral CT computed tomography x-ray system. The recall was initiated because there is a possibility that screws holding an internal portion of the gantry, known as the Reaction Ring, to the scanner's main bearing may come loose.
If the screws come loose, the parts will not be expelled from the machine, but a noise may be heard coming from the gantry. The affected devices were manufactured between March 5, 2009, and the present. The distribution pattern includes 107 domestic accounts, 15 US Government accounts, 682 foreign accounts, 3 Mexico accounts, and 12 Canada accounts.
Healthcare facilities should contact Philips Medical Systems for instructions on how to address the issue. The source text does not specify a consumer action for general public, as these are medical devices used in professional settings.
The recalled product
- Product
- Philips Healthcare IQon Spectral CT computed tomography x-ray system
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 50
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 (1)
- IQon Spectral CT 728332 Devices manufactured 03/05/2009 to present.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 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.
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