Operating Table Extension Tabletop May Drop, Creating Patient Fall Hazard
The back rest of Getinge operating table extension tabletops may drop unexpectedly, posing a fall hazard to patients. No injuries have been reported.
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: FDA Class II medical device recall involving a mechanical hazard (sudden unintended back rest drop) that could result in patient falls and head injuries. No illnesses or injuries have been reported, placing this in the High category per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Getinge USA Sales Inc is recalling extension tabletops (models 1140.20F0 and 1140.20AN) for its Operating Table System 1140. The product was distributed to 5 units in the United States and 1,008 units internationally.
The back rest may unintentionally drop suddenly, which could result in adverse health consequences if a patient falls, particularly if the patient strikes their head on the floor.
These units were distributed in the United States in Massachusetts, New Jersey, South Carolina, and Tennessee, as well as internationally across numerous countries including Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Japan, Mexico, the United Kingdom, and others. The product was discontinued in 2008.
Affected healthcare facilities should immediately remove these operating tables from service. Contact Getinge USA Sales Inc for instructions on replacement or proper disposal.
The recalled product
- Product
- Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
- Manufacturer
- Getinge Usa Sales Inc
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 (5)
- No UDI - product discontinued in 2008. Part Number 1140.20F0: Serial Nos. 3
- 8
- 9
- 10 Part Number 1140
- 20AN: Serial No. 851
Distribution
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