Miniaturized TEE probes recalled over reversed articulation from assembly error
ImaCor is recalling 45 ClariTEE miniaturized TEE probes after a production assembly error left articulation reversed, so moving the lever forward anteflexed the tip instead of retroflexing it.
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: a probe that flexes opposite to the operator's control input inside a patient is a physical hazard, and no injuries are reported.
Plain-English summary
ClariTEE Miniaturized TEE probes, model CLT-010, used with the ImaCor model ZHH mobile ultrasound, are being recalled.
A production assembly error resulted in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
The recall covers 45 units carrying UDI-DI 00861589000108, lot number 20261209, distributed in South Carolina, New Jersey, Pennsylvania, Florida and Georgia. The FDA has classified the action as Class II.
The enforcement record describes the reversed control behaviour and reports no injuries. Facilities holding the affected lot should follow ImaCor's instructions.
The recalled product
- Product
- ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
- Manufacturer
- ImaCor Inc.
- Affected units
- 45
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 (3)
- Model CLT-010
- UDI-DI 00861589000108
- Lot number: 20261209.
Distribution
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