ARCHITECT c8000, c16000, c4000 Processing Module (2018-07-20)
- Starting date:
- July 20, 2018
- Posting date:
- August 17, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67380
Affected products
- ARCHITECT c8000 Processing Module
- ARCHITECT c16000 Processing Module
- ARCHITECT c4000 Processing Module
Reason
If architect pressure monitoring is not communicating properly during power up, the system will notify the user with a pop-up message including error codes 3580 to 3585 or 5381. The architect operations manual section 10 provides instructions on how to correctly resolve these errors. If the user chooses to transition the architect to the running status without successfully resolving error codes 3580 to 3585 or 5381, there is the potential to generate incorrect results as the pressure monitoring system is inactive.
Affected products
-
ARCHITECT c8000 Processing Module
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 01G06-01
- 01G06-11
Companies
- Manufacturer
-
Abbott Laboratories Diagnostcis Division
100 Abbott Park Road
Abbott Park
60064
UNITED STATES
B. ARCHITECT c16000 Processing Module
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
03L77-01
03L77-84
Companies
- Manufacturer
-
Abbott Laboratories Diagnostcis Division
100 Abbott Park Road
Abbott Park
60064
UNITED STATES
C. ARCHITECT c4000 Processing Module
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
02P24-01
02P24-40
Companies
- Manufacturer
-
Abbott Laboratories Diagnostcis Division
100 Abbott Park Road
Abbott Park
60064
UNITED STATES