Philips Recalls MX 16-slice CT Scanners Due to Bolt Failure Risk
Philips Medical Systems is recalling 328 MX 16-slice CT Scanner Systems because a bolt may fail, causing the oil accumulator to detach from the tube housing assembly.
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. The hazard involves a mechanical component failure (bolt failure) that could lead to internal component detachment, posing a risk of harm to patients or operators, but no specific injuries or deaths are reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 328 units of the MX 16-slice CT Scanner System, models 728131 and 728132. The recall was initiated on August 24, 2012, after the firm discovered that a bolt attaching the oil accumulator within the gantry may fail. This failure could result in the oil accumulator detaching from the tube housing assembly within the gantry.
The affected devices are distributed worldwide, including in the United States and numerous international countries. The specific serial numbers affected are listed in the structured product information provided by the agency. The MX 16-slice CT Scanner System is used as a whole body computed tomography X-ray system.
Healthcare facilities and consumers should stop using the affected units and contact Philips Medical Systems for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 328
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)
- System Code #
- 728131
- Serial #: EP16E090001-EP16E090004
- EP16E090006-EP16E090015
- EP16E100001- EP16E100004
- EP16E100006
- EP16E100008- EP16E100063
- EP16E100067
- EP16E100069- EP16E100113
- EP16E110001- EP16E110065
- EP16E110067-EP16E110070
- EP16E110074-EP16E110075
- EP16E110077-EP16E110078
- EP16E110080
- EP16E110083- EP16E110085
- EP16E110088- EP16E110112
- EP16E110115- EP16E110119
- EP16E120001- EP16E120014
- EP16E120016
- EP16EB110003- EP16ER100007
Distribution
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