PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported November 27, 2013

TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is u

The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.

Recall #
Z-0342-2014
Affected scope
15 components
Initiated
October 28, 2013
Verify with FDA Devices →
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Trumpf Medical Systems, Inc. recalled TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU Use of the Leg Secti… - a moderate-severity action.

TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU Use of the Leg Secti… was recalled by Trumpf Medical Systems, Inc. in November 27, 2013. Reason: The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.. Check the official notice for the remedy. Verify recall #Z-0342-2014 with the FDA Devices before acting.

The recall

Trumpf Medical Systems, Inc. issued this moderate-severity FDA Devices recall-The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame..

Moderate
severity level
Class II
classification
November 27, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0342-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is used to position the patients legs during pre-op and post-op surgery.

Reason for recall

The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-0342-2014
Date reported November 27, 2013
Date initiated October 28, 2013
Recalling firm Trumpf Medical Systems, Inc.
Firm location Charleston, SC
Affected scope 15 components
Distribution US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-0342-2014) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
TruSystem Surgical Table (TS7000)  Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the use of patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. The Leg Section One Part Light HU is attached to coupling point L on the operating table and is used to position the patients legs during pre-op and post-op surgery.. Recalled by Trumpf Medical Systems, Inc.. Units affected: 15 components.
Why was this product recalled?
The coupler point (hood) of the Leg Section One Part Light may become detached from the leg section frame.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 27, 2013. Severity: Moderate. Recall number: Z-0342-2014.
Where was the recalled product distributed?
Distribution: US Distribution including the states of CA, IL, NJ, NY, NC, TX, WA and SC..
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported November 27, 2013. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026