Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500

FDA device recall Z-0182-2023 · posted 2022-11-04 · Open, Classified

Recall details

Recalling firm

SEDECAL SA

Reason for recall

Due to un-commanded movement of mobile x-ray unit.

Action taken

Sedecal SA provided Canon Medical Systems USA (CMSU) the sole distributor of the Soltus system in the U.S. an "URGENT: ADVISORY NOTICE" to communicated to CMSU's customers. On 07/28/2022, CMSU sent the "URGENT: ADVISORY NOTICE" Letter via USPS Certified to inform customer of an issue with erratic movements related with Soltus 500 Mobile X-Ray units. According to reports, the users were trying to turn the systems to the left or to the right when it suddenly started moving backwards at a high speed. Customer are instructed to: 1. Do not continue using the unit when in error condition (magenta LED status lights blinking) if the error cannot be reset. 2. In case of undesired or erratic movements perceived by the user, release the handle and park the unit immediately. Do not try to fight against the erratic movements of the system with the handle. 3. Call service immediately to restore the unit to operational status. 4. If the unit most be moved, power off the unit (do not use the emergency stop button) and use either the manual driving brake release button or the manual clutch screws (See Manual (OM-0474R11) sections 3.6.1.3 and 3.6.1.6 for model Soltus 500. See Manual (OM-0475R7) sections 3.6.1.3 and 3.6.1.5 for model Soltus 450. For questions, contact Gary Becker, Regulatory Affairs Manager at 800-421-1968 or gmbecker@us.medical.canon or the Canon Service Rep at 800-521-1968.

Root cause

Software design

Status

Open, Classified

Product code

IZL

Quantity affected

155 systems

Distribution

U.S.: KY, WI, FL, DE, WV, CA, MO, NY, NC, AL, AR, MS, GA, IL, IA, TN, KS, KY, IN, HI, OH, WY, PA, NV, RI, UT, AZ, OK, MN, ME, MT, WA, VA, SD, MI, LA, and TX O.U.S.: N/A

Date initiated

2022-08-12

Date posted

2022-11-04

Location

Algete, Spain

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