HarmonyAIR dual flat panel monitor yokes may detach from spring arm
Dual Flat Panel Monitor accessories for HarmonyAIR A-Series Surgical Lighting Systems are being recalled because the yoke assembly may detach from the spring arm. 167 units are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: a suspended monitor assembly above a surgical field may come away from its arm, with no injury reported in the source.
Plain-English summary
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems are being recalled. The action covers 167 units, UDI 00724995203245, identified by the serial numbers in the recall notice.
The stated reason is that the DFPM yoke assembly may detach from the spring arm. According to the notice, should the yoke assembly detach from the spring arm, it would not be expected to fully detach but rather to hang from the wiring within the yoke assembly. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was worldwide, including nationwide in the United States, Puerto Rico and Canada. The systems are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected units using the UDI and serial numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
- Manufacturer
- Steris Corporation
- Hazard
- yoke-detachment
- suspended-load
- surgical-lighting
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI: 00724995203245: Serial Numbers: 0400224028
- 0401625167
- 0401625171
- 0401625180
- 0401625185
- 0401625190
- 0402022165
- 0402022169
- 0402422003
- 0402622007
- 0402925148
- 0403122053
- 0403122057
- 0403125009
- 0403223079
- 0403223083
- 0403223087
- 0403223091
- 0403321066
- 0403321070
Distribution
Distributed nationwide across the United States.
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