Trumpf Medical Systems Recalls Patient Transport Shuttles Due to Tilting Hazard
Trumpf Medical Systems is recalling 1,284 patient transport shuttles because the table top may tilt down quickly in the maximum Trendelenburg position.
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 medical device with a mechanical defect that poses a risk of harm (injury) to patients or staff, but the source text does not report any actual injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Trumpf Medical Systems, Inc. is recalling 1,284 patient transport shuttles with Trendelenburg quick adjustment functions. The affected models include the Shuttle 2.7, Shuttle 2.7 360, Shuttle 3.7, and Shuttle 3.7 360, which are used with Jupiter, Mars, Titan, TruSystem, and Saturn operating table systems.
The recall was initiated after complaints were received regarding the table top on the transporter tilting down quickly when in the maximum Trendelenburg position. This defect poses a risk of injury to patients or medical staff during transport or positioning.
The affected units were distributed worldwide, including in the United States (specifically Massachusetts and Texas) and various foreign countries. Users should stop using the affected shuttles and contact Trumpf Medical Systems for instructions on repair or replacement.
The recalled product
- Product
- Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems). The shuttle is intended for the following applications: 1. Transfer, transport and storage of exchangeable table tops in the Trumpf…
- Manufacturer
- Trumpf Medical Systems, Inc.
- Affected units
- 1,284
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 (11)
- Product: Shuttle 2.7
- Material Number: 1254362
- Serial Number Range: 100801175 101349420
- Product: Shuttle 2.7 360
- Material Number: 1459862
- Serial Number Range: 100843669-101212847
- Product: Shuttle 3.7
- Material Number: 1254363
- Serial Number Range: 100180383-101290987 and Product: Shuttle 3.7 360
- Material Number: 1459863
- Serial Number Range: 100787418-101334652.
Distribution
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