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Essenta DR (2013-12-05)
- Starting date:
- December 5, 2013
- Posting date:
- January 24, 2014
- 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-37639
Recalled product
- Essenta DR
Reason
Philips has become aware that if during system installation, the screws holding the C-Arm were mounted using thread locking compound (e.g. loctite), then the corresponding thread inserts inside the C-Arm casting may loosen when the C-Arm is dismantled. If, after reassembly of the system, the lossened thread inserts become detached from the casting, the C-Arm would no longer be securely held in position and could fall. The C-Arm is most often dismantled and reassembled when the system is moved to another location.
Affected products
A. Essenta DR
Lot or serial number
- 376657 / Serial number: 08000030
- 396940 / Serial number: 08000073
- 397186 / Serial number: 08000042
- 423573 / Serial number: 09000014
- 433527 / Serial number: 09000054
Model or catalog number
- 9890 010 87381
Companies
- Manufacturer
-
Philips Medical Systems DMC GmbH
Rontgenstrabe 24
Hamburg
22335
GERMANY