IQon Spectral CT recalled over rotor fasteners that may be undertorqued
Philips is recalling 52 IQon Spectral CT units because fasteners attaching the rotor to the gantry bearing may not be torqued to specification.
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: Scored 3 under the risk-of-harm criterion: the firm states unsecured rotor parts may potentially be expelled during gantry rotation, and no such event or injury has been reported.
Plain-English summary
The Philips IQon Spectral CT, product code (REF) 728332, is being recalled by Philips North America Llc.
The record states that as part of the CT system sub assembly, 32 fasteners are used to attach the rotor to the bearing within the gantry, and that one or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. The record states that while there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
The record lists 52 units under UDI-DI 00884838059542, with serial numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should follow Philips' instructions.
The recalled product
- Product
- IQon Spectral CT; Product Code (REF): 728332;
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — CT scanner
- Affected units
- 52
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 (20)
- Product Code (REF): 728332
- UDI-DI: 00884838059542
- Serial Numbers: 60128
- 60141
- 60151
- 60161
- 60171
- 60181
- 60129
- 60142
- 60152
- 60162
- 60172
- 60182
- 60130
- 60143
- 60153
- 60163
- 60173
- 60132
Distribution
Part of a larger recall action
This product is one of 4 recalled by Philips North America Llc 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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