Trumpf Medical Systems, Inc. FDA Record
Trumpf Medical Systems, Inc. has 31 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Trumpf Medical Systems, Inc." is on file.
- Latest recall
- Z-0824-2018 · Class II · Dec 15, 2017
- Latest 510(k)
- Jun 13, 2001
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 31 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0824-2018 | Class II | Camera System, Television, Surgical without audio Intended for transmission and documentation of… | Dec 15, 2017 |
| Z-0391-2017 | Class II | OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H… | Oct 25, 2016 |
| Z-0041-2017 | Class II | Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery… | Jul 10, 2016 |
| Z-0040-2017 | Class II | Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number… | Jul 10, 2016 |
| Z-0042-2017 | Class II | Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material… | Jul 10, 2016 |
| Z-0043-2017 | Class II | Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB)… | Jul 10, 2016 |
| Z-0759-2016 | Class II | Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan… | Jan 19, 2016 |
| Z-0563-2016 | Class II | Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System… | Nov 2, 2015 |
| Z-2353-2015 | Class II | Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF… | Jul 27, 2015 |
| Z-2354-2015 | Class II | Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The… | Jul 27, 2015 |
| Z-2355-2015 | Class II | Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The… | Jul 27, 2015 |
| Z-2356-2015 | Class II | Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF… | Jul 27, 2015 |
| Z-2357-2015 | Class II | Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. The TRUMPF… | Jul 27, 2015 |
| Z-0921-2015 | Class II | IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940. Patient… | Dec 3, 2014 |
| Z-0926-2015 | Class II | Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649. Patient… | Dec 3, 2014 |
| Z-0927-2015 | Class II | IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient positioning… | Dec 3, 2014 |
| Z-0919-2015 | Class II | Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919… | Dec 3, 2014 |
| Z-0928-2015 | Class II | Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048. Patient… | Dec 3, 2014 |
| Z-0920-2015 | Class II | Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.) 102284378. Patient… | Dec 3, 2014 |
| Z-0918-2015 | Class II | Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915. Patient… | Dec 3, 2014 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K011693 | TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 | Jun 13, 2001 |
Trumpf Medical Systems, Inc. and the FDA: common questions
Has Trumpf Medical Systems, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Trumpf Medical Systems, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Trumpf Medical Systems, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Trumpf Medical Systems, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
Has Trumpf Medical Systems, Inc. had an FDA recall?
Yes. Trumpf Medical Systems, Inc. has 31 FDA recalls on record. The most recent started Dec 15, 2017.
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