Trumpf Medical Systems, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 38
At a glance
Market reach
- United States
- FDA recalls
What Trumpf Medical Systems, Inc. makes
Trumpf Medical Systems, Inc. manufactures surgical lighting systems, including models 301, 501, 701, and 1001, designed for use in operating rooms to provide illumination during procedures.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 38 recalls initiated by Trumpf Medical Systems, Inc., the earliest on 2009-02-27 and the most recent on 2017-12-15. By recorded status: 37 terminated and 1 with another status. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 15 Dec 2017 Z-0824-2018 Class II Terminated The radiated emission from the TruVidia" Wireless Receiver is above the normative accepted limits, in which the radiated emission may interact with other devices in the operating room and cause them not to function properly.
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- 15 Dec 2017 Z-0824-2018 Class II Terminated The radiated emission from the TruVidia" Wireless Receiver is above the normative accepted limits, in which the radiated emission may interact with other devices in the operating room and cause them not to function properly.
2016
- 25 Oct 2016 Z-0391-2017 Class II Terminated Trumpf has identified six incidents of pinched cables.
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- 10 Jul 2016 Z-0040-2017 Class II Terminated Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
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- 10 Jul 2016 Z-0041-2017 Class II Terminated Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
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- 10 Jul 2016 Z-0042-2017 Class II Terminated Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
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- 10 Jul 2016 Z-0043-2017 Class II Terminated Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.
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- 19 Jan 2016 Z-0759-2016 Class II Terminated Complaints were received of the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position.
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- 25 Oct 2016 Z-0391-2017 Class II Terminated Trumpf has identified six incidents of pinched cables.
2015
- 2 Nov 2015 Z-0563-2016 Class II Completed 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.
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- 27 Jul 2015 Z-2353-2015 Class II Terminated Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
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- 27 Jul 2015 Z-2354-2015 Class II Terminated Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
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- 2 Nov 2015 Z-0563-2016 Class II Completed 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.
Show the 25 most recent of 38 recalls
2015
- 27 Jul 2015 Z-2355-2015 Class II Terminated Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
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- 27 Jul 2015 Z-2356-2015 Class II Terminated Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
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- 27 Jul 2015 Z-2357-2015 Class II Terminated Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
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- 27 Jul 2015 Z-2355-2015 Class II Terminated Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
2014
- 3 Dec 2014 Z-0918-2015 Class II Terminated Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
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- 3 Dec 2014 Z-0919-2015 Class II Terminated Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
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- 3 Dec 2014 Z-0920-2015 Class II Terminated Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
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- 3 Dec 2014 Z-0921-2015 Class II Terminated Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
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- 3 Dec 2014 Z-0922-2015 Class II Terminated Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
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- 3 Dec 2014 Z-0923-2015 Class II Terminated Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
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- 3 Dec 2014 Z-0924-2015 Class II Terminated Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
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- 3 Dec 2014 Z-0925-2015 Class II Terminated Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
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- 3 Dec 2014 Z-0926-2015 Class II Terminated Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
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- 3 Dec 2014 Z-0927-2015 Class II Terminated Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
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- 3 Dec 2014 Z-0928-2015 Class II Terminated Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
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- 3 Dec 2014 Z-0929-2015 Class II Terminated Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
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- 3 Dec 2014 Z-0918-2015 Class II Terminated Complaints have been reported of unintended movement occurring during surgical cases due to the use of damaged JUPITER remotes
Frequently asked questions
How many devices does Trumpf Medical Systems, Inc. have in the registry?
The registry currently lists 1 device for Trumpf Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Trumpf Medical Systems, Inc.'s devices?
Among its 1 most recently registered device, Trumpf Medical Systems, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Trumpf Medical Systems, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Trumpf Medical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Trumpf Medical Systems, Inc.?
FDA recall records list 38 recalls initiated by Trumpf Medical Systems, Inc., the most recent initiated on 15 Dec 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Trumpf Medical Systems, Inc. in the registry?
The most recently registered devices listed for Trumpf Medical Systems, Inc. include TRUMPF SURGICAL LIGHTS, MODELS 301, 501, 701, 1001.