Reported Mar 4, 2015 · Terminated
Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively…
Spacelabs Healthcare Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spacelabs Healthcare Inc · 35301 SE Center St · Snoqualmie, WA · 98065-9216
Is this the product you have?
- Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
- Lot codes and dates
- SERIAL NUMBERS OF UNITS IN THE US
702 of 702 codes
1390-0001971393-0000241393-0001661393-0001991393-0034511393-0039701393-0042221393-0043061393-0043191393-0044571393-0049621393-0053651393-0061561393-0066351393-0066361393-0068151393-0068161393-0068391393-0068401393-0068411393-0068421393-0068441393-0068451393-0068461393-0068471393-0069761393-0069771393-0069781393-0069791393-0069801393-0069811393-0069821393-0069831393-0069841393-0069851393-0069861393-0069871393-0070171393-0070201393-0070211393-0070221393-0070241393-0070251393-0070261393-0070271393-0070281393-0070291393-0070301393-0070311393-0070321393-0070331393-0070341393-0070351393-0070361393-0070371393-0070381393-0070391393-0070401393-0070411393-007042
- SERIAL NUMBERS OF UNITS OUTSIDE THE US
876 of 876 codes
1393-0000111393-0001621393-0001721393-0002351393-0002361393-0002371393-0002381393-0002391393-0002401393-0002411393-0003351393-0003461393-0003471393-0003481393-0003491393-0003501393-0003511393-0003521393-0003531393-0003541393-0003551393-0010601393-0010661393-0031461393-0031481393-0040281393-0044271393-0049651393-0049721393-0049731393-0049821393-0055101393-0069631393-0069641393-0069651393-0069661393-0069671393-0069681393-0070181393-0070191393-0070621393-0070631393-0071531393-0071541393-0071551393-0071561393-0071571393-0071581393-0071591393-0071601393-0072901393-0072911393-0072921393-0072931393-0072941393-0073251393-0073261393-0073271393-0073281393-007329
- SERIAL NUMBERS OF UNITS IN THE US
- Amount recalled
- total 1578 units (702 units in the US and 876 outside US)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled because the firm has received multiple reports of XPREZZON monitors failing to boot up or returning to factory default configuration settings following power on or reset.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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