Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme ...

FDA Device Recall #Z-2311-2012 — Class II — May 29, 2012

Recall Summary

Recall Number Z-2311-2012
Classification Class II — Moderate risk
Date Initiated May 29, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Trumpf Medical Systems, Inc.
Location Charleston, SC
Product Type Devices
Quantity 402 units

Product Description

Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.

Reason for Recall

Cracks can arise on the welded seam on the rear joint.

Distribution Pattern

Worldwide Distribution - USA including CA, OH, OK, NY, PA, TX, WY and the country of Canada

Lot / Code Information

I.D. on nameplate: FA AC3 or FA AC3000; Material #1920632, Serial #011201602557 to 011201602588; Serial #011203602617 to 011202602621; Serial #011203602676 to 011203602695; Serial #011203602756 to 011203602775; Serial #011203602776 to 011203602795; Serial #011204602798 to 011204602817; Serial #011204602861 to 011204602880; Serial #011204602970 to 011204602989; Serial #011205603032 to 011205603081; Serial #011206603118 to 011206603167; Serial #011206603168 to 011206603217; Serial #011207603303 to 011207603314; Serial #011208603316 to 011205603333; Serial #011208603361 - Serial #011209603431 to 011209603462; Serial #011210603572 to 011210603597 and Material #1851710, Serial #3705776 to 3705777 and Serial #4105778 to 4105781.

Other Recalls from Trumpf Medical Systems, Inc.

Recall # Classification Product Date
Z-0824-2018 Class II Camera System, Television, Surgical without aud... Dec 15, 2017
Z-0391-2017 Class II OR Table, Top U26 H V, Model # 1909793; OR Tabl... Oct 25, 2016
Z-0042-2017 Class II Floor Mounting Column TS 7500 U, Material Numbe... Jul 10, 2016
Z-0043-2017 Class II Operating Table TruSystem 7000 U, Material Numb... Jul 10, 2016
Z-0040-2017 Class II Mobile Column TruSystem 7500, Material Number 1... Jul 10, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.