Getinge Operating Table System Recalled for Hydraulic Leakage Risk
Getinge Group Logistics America, LLC is recalling 4,288 Operating Table Systems due to a potential hydraulic leakage that could cause unintended table movement.
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, fitting the criteria for a High severity score.
Plain-English summary
Getinge Group Logistics America, LLC is recalling 4,288 units of the Operating Table System. The recall is due to a potential for hydraulic leakage at the inclination function. This defect may result in unintended Trendelenburg or anti-Trendelenburg movement of the table top, depending on patient positioning.
The affected units are distributed domestically across 38 U.S. states and territories, as well as in numerous foreign countries including Argentina, Australia, Canada, China, Germany, Japan, and the United Kingdom. Specific part numbers and serial numbers are listed in the agency's structured product information.
The hazard associated with this recall is that the unintended movement of the table top may lead to the patient having to be transferred to another operating room table, causing a delay in the procedure. No injuries or illnesses have been reported in the source text.
The recalled product
- Product
- Operating Table System
- Manufacturer
- Getinge Group Logistics America, LLC
- Category
- Medical Device — Operating Table
- Affected units
- 4,288
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)
- Part Number: 118001A0
- 118001B0
- 118001B1
- 118001B2
- 118001B3
- 118001B4
- 118001C0
- 118001D0. UDI code: 04046768031500
- 04046768031531
- 04046768040700
- 04046768088351
- 04046768088061
- 04046768124752
- 04046768031555
- 04046768031579. Serial Number: 1 3402
- 1 1028
- 1 1264
- 1 401
- 3 74
- 1 81
Distribution
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