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FDA device recall Z-1150-2018 · posted 2018-03-20 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.

Action taken

The firm, Siemens Healthineers, sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated 1/5/2018 to its consignees. The letter describes the product, problem and actions to be taken. The consignees were instructed to follow their standard emergency procedures in place in the event of system failures; to consider reinforcing these emergency procedures until the update has been completed. Siemens will replace all affected plastic couplings with metal couplings. The Siemens service organization will contact the consignees to arrange a date to perform this corrective action.If the device has been sold and is therefore no longer in your possession, please forward this field correction notice to the new owner. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.

Root cause

Process control

Status

Terminated

Product code

JAA

Quantity affected

22

Distribution

US Distribution in the following U.S. states: AZ, CA, FL, IA, IL, LA, MI, NC, NJ, OH, OK, and TX.

Date initiated

2018-01-05

Date posted

2018-03-20

Date terminated

2018-08-23

Location

Malvern, PA

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