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FDA device recall Z-1284-2016 · posted 2016-03-31 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. This leak can occur sporadically in affected systems.
- Action taken
- Siemens sent an Important Customer Safety Notice to customers on February 18, 2016 informing them that their service organization will contact them to arrange a date to perform the corrective action (replacement of affected plastic couplings with metal couplings to prevent fluid leaks). Customers were advised to contact Siemens service organization for an earlier appointment at 1-800-888-7436.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 986 systems in total
- Distribution
- US Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI,
- Date initiated
- 2016-02-18
- Date posted
- 2016-03-31
- Date terminated
- 2017-08-08
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTIS ZEE AND ZEEGO (K073290) | Siemens Medical Solutions USA, Inc. | 2008-02-11 |