Recall Z-0914-2015— Siemens Medical Solutions USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2014-04-08, terminated 2016-12-23. It names 3 FDA 510(k) clearances: K992731, K982387, K952109. Product: e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.. Reason: There is a potential for patient finger injury on the e.cam systems..
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-08
- Terminated
- 2016-12-23
- Firm location
- Hoffman Estates, IL, United States
510(k) clearances named in this recall
3 on FDA's record- K992731 — E.CAM COMPUTER
- K982387 — E.CAM EXTRA HIGH ENERGY COLLIMATOR
- K952109 — IP500 NUCLEAR GAMMA CAMERA SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
Reason for recall
There is a potential for patient finger injury on the e.cam systems.
Data sourced from openFDA. This site is unofficial and independent of the FDA.