CLASS II Device recall · Reported 6 Jan 2016 · FDA Enforcement Report
Ceiling Mounted Surgical Light System TruLight 3000/5000 recalled
Trumpf Medical Systems is recalling Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical, distributed nationwide in the US. The recall was initiated on 2 Nov 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0563-2016
- FDA event ID
- 72542
- Recalling firm
- Trumpf Medical Systems, Charleston, SC
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 2 Nov 2015
- FDA classified
- 31 Dec 2015
- Reported
- 6 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 2 Nov 2015 | Recall initiated by company | |
| 31 Dec 2015 | Classified by FDA | +59 days |
| 6 Jan 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.
Product as listed by the FDA
Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
Where it was distributed
USA (nationwide) Distribution to the states of : AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KY, ME, MA, MN, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WY., and Internationally to Canada.
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyMassachusettsMaineMinnesotaMissouriNorth CarolinaNorth Dakota
Questions about this recall
Is Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical recalled?
Yes. Trumpf Medical Systems recalled Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical on 2 Nov 2015. The recall is Class II and its status is Completed. Recall number Z-0563-2016.
Why was it recalled?
The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.
Which lots are affected?
4028110 - iLED Single; 4028210 - iLED duo; 4028310 - iLED trio/quad; 4038110 - TruLight single; 4038210 - TruLight duo; 4038310 - TruLight trio/quad; 1565068 - iLED single (TUSM); 1565160 - iLED duo (TUSM); 1565161 - iLED trio/quad (TUSM); 1574759 - TruLight single (TUSM); 1574850 - TruLight duo (TUSM); 1574851 - TruLight trio/quad (TUSM)
Where was it sold?
USA (nationwide) Distribution to the states of : AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KY, ME, MA, MN, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WY., and Internationally to Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Trumpf Medical Systems
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|---|---|---|---|---|---|
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