Philips MX8000 CT Scanner Recall Due to Unexpected Couch Descent
Philips is recalling 153 MX8000 CT scanners because the patient couch may descend unexpectedly during an exam.
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, which corresponds to a score of 3 (High) per the rubric.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 153 units of the MX8000 Dual v. EXP Computed Tomography (CT) X-ray systems. These systems are intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
The recall was initiated after the firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so. The affected units were distributed in China.
The specific units involved are identified by System Code # 728130 and Serial Numbers 8107, 8128, 8152, 8157, 8171, 8212, 8236, 8245, 8263, 8320, and 8357. The source text does not specify further consumer actions or report any injuries.
The recalled product
- Product
- MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Affected units
- 153
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 (13)
- MX8000 Dual v. EXP: System Code #
- 728130
- Serial #
- 8107
- 8128
- 8152
- 8157
- 8171
- 8212
- 8236
- 8245
- 8263
- 8320 & 8357.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 11 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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